7 Manufacturing Plants jobs in Indianapolis
Infrastructure & Capital Projects - Project Production Management (PPM)
46082 Carmel, Indiana
Accenture
Posted today
Job Viewed
Job Description
JOB TITLE Infrastructure & Capital Projects - Project Production Management (PPM)
This role can sit anywhere in the US as long as it is near an Accenture Corporate Office
WHO WE ARE:
We are I ndustry X, Infrastructure & Capital Projects . We are reinventing how capital projects are planned, designed, managed and executed. We help our clients efficiently and sustainably build and upgrade the factories, plants, networks, grids, transport and public infrastructure we need to live and work. ? ? Local knowledge backed by global capabilities and experience. That's how we deliver better outcomes for our clients. Our experienced program and project managers work on the ground, hand in hand with our industry experts, strategists, technologists and ecosystem partners to help us improve project performance and outcomes. We balance the need to make improvements immediately with the desire to transform the way projects are delivered in the future. ? ? From inception to completion, we use deep "hands on" design and construction experience coupled with data, technology and AI to help bring projects in on time and on budget. While helping to execute today, we focus on building a digital backbone to improve collaboration between stakeholders, reduce risk and use resources more efficiently. We digitally enable the workforce to help them predict issues, work more effectively and ensure their safety. ? ? Together with our clients we are using technology and human ingenuity to reinvent the way our built world is created, operated and maintained. ? Visit us here to find out more about Industry X.0 ( HE WORK:
As a (PPM) , you will play a pivotal role in supporting the delivery of large-scale, complex capital projects across industries such as data centers, oil and gas, civil infrastructure, and industrial sectors. This position provides a unique opportunity to work with sophisticated customers on some of the most ambitious and critical projects globally.
You will facilitate the implementation of solutions, focusing on production control processes such as production planning, scheduling, and execution optimization. You will collaborate closely with multidisciplinary teams, enabling project stakeholders to adopt advanced construction methods and modern execution strategies, ensuring improved project outcomes.
+ ( Work location is f lexible or remote or onsite or onsite at delivery center)
+ Flexible : The work location for this role will include a mix of working remotely, onsite at a client or in an Accenture office or center.
+ Remote : This role allows for remote work for the majority of your work hours.
+ Onsite at client site : The work location for this role will include a mix of working remotely and working onsite with our clients and partners to enable delivery and cultivate our client relationships.
+ Onsite at delivery center: You will be onsite at our delivery center for the majority of your work hours.
+ PPM/LPS Solutions Implementation:
+ Facilitate the implementation and use of Project Production Management solutions on-site, working directly with multidisciplinary project teams.
+ Apply production control processes, including scheduling and planning, to enhance work execution and optimize project outcomes.
+ Training and Education:
+ Educate, train, and guide project stakeholders in the effective use of PPM/LPS solutions.
+ Identify opportunities for work optimization through analytics and provide actionable insights.
+ Execution Support:
+ Develop implementation progress reports, post-implementation analyses, and analytics to demonstrate value delivery.
+ Support project delivery through the integration of Advanced Work Packaging (AWP), Last Planner System, and constructability solutions.
+ Collaboration and Process Integration:
+ Collaborate with general contractors, subcontractors, and suppliers to align project execution methods.
+ Translate project controls schedules and analytics into actionable daily construction planning for field teams.
+ Advanced Execution Strategies:
+ Facilitate the adoption of advanced construction methodologies, including modularization, off-site fabrication, and pre-assembly.
+ Support execution approaches like Integrated Project Delivery (IPD), Progressive Design-Build (PDB), and Lean Construction principles.
+ Analytics and Reporting:
+ Interpret and present analytics captured through production plans and provide continuous feedback to improve project performance.
+ Monitor work execution progress and identify opportunities for improvement.
With all our roles, there is some in-person time for collaboration, learning and building relationships with clients, peers, leaders and communities. As an employer, we will be as flexible as possible to support your specific work/life needs.
Job Requirements:
Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements.
HERE'S WHAT YOU'LL NEED:
+ Minimum of 5 years of experience in the delivery and optimization of major capital projects in sectors such as data centers, oil and gas, civil infrastructure, and industrial construction.
+ Minimum of 5 years of experience in field execution for general contracting, progressing into strategic advisory roles for large, complex projects.
+ Minimum of 5 years of hands-on experience with Production Control systems, Lean Construction methods (e.g., Last Planner System/Pull Planning), and Advanced Work Packaging (AWP).
+ Bachelor's degree or minimum of 6 years of related work experience
BONUS POINTS IF YOU HAVE:
+ Strong background in construction field operations and advanced construction methods.
+ Experience implementing project execution methodologies and leveraging supporting technologies.
+ Deep understanding of constructability principles and advanced contracting approaches such as Integrated Project Delivery (IPD) and Progressive Design-Build (PDB).
+ Global experience delivering PPM solutions and collaborating with senior customer stakeholders.
+ Proficiency in analytics and reporting to monitor project progress and performance.
WHAT'S IN IT FOR YOU:
+ Work on the largest and best projects : We advise and deliver on our clients largest , most complex capital programs, enabling more efficient use of capital and higher ROI.
+ Work with purpose : Be part of creating positive change and making the world better for our people, our clients, and the communities where we live and work . Embrace ? sustainability ( ? with ? everything ? you ? do - from how we service our clients, partners and communities ? to ? how ? we operate as a responsible business? ?
+ Work with reach: When you join us, you'll work with the top companies with leaders from every industry. Across 120 countries and 40 industries, we work as one team with a common goal-to create 360-degree value by embracing change. While our global reach is impressive, you'll find that our I&CP Americas team is highly accessible and collaborative? ?
+ Grow and Thrive Professionally: We invest in you. With a $1.1 billion commitment to our team's learning and development, your growth is prioritized. Whether through leadership training, creative problem-solving workshops, or technical upskilling you have the resources to excel. Our flexible, omni-connected work model also supports a healthy work-life balance, adapting to both professional needs and personal circumstances. ?
+ Bring your true-self to work: Our commitment to our 775,000 people from a variety of cultures, beliefs and backgrounds ( makes us more innovative, and lets you bring self to work . Be on the forefront of technology that's creating a better future for all. Learn more ( ?
+ Make a difference: Connect your passions and purpose with your profession with opportunities to participate in corporate citizenship, Employee Resource Groups, eco- actions and development-partnership projects? ?
+ Awards and Recognition : ?We are recognized as leaders within program management and capital project professional services, having been ranked as the 7th largest program management firm by ENR (Engineering News Record). Accenture is recognized among the World's Best Workplaces - Ranked #10 on the World's Best Workplaces by Great Place to Work® and Fortune? ?
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired in California, Colorado, District of Columbia, Illinois, Maryland, Minnesota, New Jersey, New York or Washington as set forth below.We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here. ( Location Annual Salary Range
California $4,400 to 293,800
Colorado 94,400 to 253,800
District of Columbia 100,500 to 270,300
Illinois 87,400 to 253,800
Minnesota 94,400 to 253,800
Maryland 94,400 to 253,800
New York/New Jersey 87,400 to 293,800
Washington 100,500 to 270,300
#LI-NA-FY25
What We Believe
We have an unwavering commitment to diversity with the aim that every one of our people has a full sense of belonging within our organization. As a business imperative, every person at Accenture has the responsibility to create and sustain an inclusive environment.
Inclusion and diversity are fundamental to our culture and core values. Our rich diversity makes us more innovative and more creative, which helps us better serve our clients and our communities. Read more here ( Employment Opportunity Statement
Accenture is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation.
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Accenture is committed to providing veteran employment opportunities to our service men and women.
For details, view a copy of the Accenture Equal Employment Opportunity and Affirmative Action Policy Statement ( .
Requesting An Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs for a disability or religious observance, please call us toll free at 1 ( , send us an email ( or speak with your recruiter.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
This role can sit anywhere in the US as long as it is near an Accenture Corporate Office
WHO WE ARE:
We are I ndustry X, Infrastructure & Capital Projects . We are reinventing how capital projects are planned, designed, managed and executed. We help our clients efficiently and sustainably build and upgrade the factories, plants, networks, grids, transport and public infrastructure we need to live and work. ? ? Local knowledge backed by global capabilities and experience. That's how we deliver better outcomes for our clients. Our experienced program and project managers work on the ground, hand in hand with our industry experts, strategists, technologists and ecosystem partners to help us improve project performance and outcomes. We balance the need to make improvements immediately with the desire to transform the way projects are delivered in the future. ? ? From inception to completion, we use deep "hands on" design and construction experience coupled with data, technology and AI to help bring projects in on time and on budget. While helping to execute today, we focus on building a digital backbone to improve collaboration between stakeholders, reduce risk and use resources more efficiently. We digitally enable the workforce to help them predict issues, work more effectively and ensure their safety. ? ? Together with our clients we are using technology and human ingenuity to reinvent the way our built world is created, operated and maintained. ? Visit us here to find out more about Industry X.0 ( HE WORK:
As a (PPM) , you will play a pivotal role in supporting the delivery of large-scale, complex capital projects across industries such as data centers, oil and gas, civil infrastructure, and industrial sectors. This position provides a unique opportunity to work with sophisticated customers on some of the most ambitious and critical projects globally.
You will facilitate the implementation of solutions, focusing on production control processes such as production planning, scheduling, and execution optimization. You will collaborate closely with multidisciplinary teams, enabling project stakeholders to adopt advanced construction methods and modern execution strategies, ensuring improved project outcomes.
+ ( Work location is f lexible or remote or onsite or onsite at delivery center)
+ Flexible : The work location for this role will include a mix of working remotely, onsite at a client or in an Accenture office or center.
+ Remote : This role allows for remote work for the majority of your work hours.
+ Onsite at client site : The work location for this role will include a mix of working remotely and working onsite with our clients and partners to enable delivery and cultivate our client relationships.
+ Onsite at delivery center: You will be onsite at our delivery center for the majority of your work hours.
+ PPM/LPS Solutions Implementation:
+ Facilitate the implementation and use of Project Production Management solutions on-site, working directly with multidisciplinary project teams.
+ Apply production control processes, including scheduling and planning, to enhance work execution and optimize project outcomes.
+ Training and Education:
+ Educate, train, and guide project stakeholders in the effective use of PPM/LPS solutions.
+ Identify opportunities for work optimization through analytics and provide actionable insights.
+ Execution Support:
+ Develop implementation progress reports, post-implementation analyses, and analytics to demonstrate value delivery.
+ Support project delivery through the integration of Advanced Work Packaging (AWP), Last Planner System, and constructability solutions.
+ Collaboration and Process Integration:
+ Collaborate with general contractors, subcontractors, and suppliers to align project execution methods.
+ Translate project controls schedules and analytics into actionable daily construction planning for field teams.
+ Advanced Execution Strategies:
+ Facilitate the adoption of advanced construction methodologies, including modularization, off-site fabrication, and pre-assembly.
+ Support execution approaches like Integrated Project Delivery (IPD), Progressive Design-Build (PDB), and Lean Construction principles.
+ Analytics and Reporting:
+ Interpret and present analytics captured through production plans and provide continuous feedback to improve project performance.
+ Monitor work execution progress and identify opportunities for improvement.
With all our roles, there is some in-person time for collaboration, learning and building relationships with clients, peers, leaders and communities. As an employer, we will be as flexible as possible to support your specific work/life needs.
Job Requirements:
Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements.
HERE'S WHAT YOU'LL NEED:
+ Minimum of 5 years of experience in the delivery and optimization of major capital projects in sectors such as data centers, oil and gas, civil infrastructure, and industrial construction.
+ Minimum of 5 years of experience in field execution for general contracting, progressing into strategic advisory roles for large, complex projects.
+ Minimum of 5 years of hands-on experience with Production Control systems, Lean Construction methods (e.g., Last Planner System/Pull Planning), and Advanced Work Packaging (AWP).
+ Bachelor's degree or minimum of 6 years of related work experience
BONUS POINTS IF YOU HAVE:
+ Strong background in construction field operations and advanced construction methods.
+ Experience implementing project execution methodologies and leveraging supporting technologies.
+ Deep understanding of constructability principles and advanced contracting approaches such as Integrated Project Delivery (IPD) and Progressive Design-Build (PDB).
+ Global experience delivering PPM solutions and collaborating with senior customer stakeholders.
+ Proficiency in analytics and reporting to monitor project progress and performance.
WHAT'S IN IT FOR YOU:
+ Work on the largest and best projects : We advise and deliver on our clients largest , most complex capital programs, enabling more efficient use of capital and higher ROI.
+ Work with purpose : Be part of creating positive change and making the world better for our people, our clients, and the communities where we live and work . Embrace ? sustainability ( ? with ? everything ? you ? do - from how we service our clients, partners and communities ? to ? how ? we operate as a responsible business? ?
+ Work with reach: When you join us, you'll work with the top companies with leaders from every industry. Across 120 countries and 40 industries, we work as one team with a common goal-to create 360-degree value by embracing change. While our global reach is impressive, you'll find that our I&CP Americas team is highly accessible and collaborative? ?
+ Grow and Thrive Professionally: We invest in you. With a $1.1 billion commitment to our team's learning and development, your growth is prioritized. Whether through leadership training, creative problem-solving workshops, or technical upskilling you have the resources to excel. Our flexible, omni-connected work model also supports a healthy work-life balance, adapting to both professional needs and personal circumstances. ?
+ Bring your true-self to work: Our commitment to our 775,000 people from a variety of cultures, beliefs and backgrounds ( makes us more innovative, and lets you bring self to work . Be on the forefront of technology that's creating a better future for all. Learn more ( ?
+ Make a difference: Connect your passions and purpose with your profession with opportunities to participate in corporate citizenship, Employee Resource Groups, eco- actions and development-partnership projects? ?
+ Awards and Recognition : ?We are recognized as leaders within program management and capital project professional services, having been ranked as the 7th largest program management firm by ENR (Engineering News Record). Accenture is recognized among the World's Best Workplaces - Ranked #10 on the World's Best Workplaces by Great Place to Work® and Fortune? ?
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired in California, Colorado, District of Columbia, Illinois, Maryland, Minnesota, New Jersey, New York or Washington as set forth below.We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here. ( Location Annual Salary Range
California $4,400 to 293,800
Colorado 94,400 to 253,800
District of Columbia 100,500 to 270,300
Illinois 87,400 to 253,800
Minnesota 94,400 to 253,800
Maryland 94,400 to 253,800
New York/New Jersey 87,400 to 293,800
Washington 100,500 to 270,300
#LI-NA-FY25
What We Believe
We have an unwavering commitment to diversity with the aim that every one of our people has a full sense of belonging within our organization. As a business imperative, every person at Accenture has the responsibility to create and sustain an inclusive environment.
Inclusion and diversity are fundamental to our culture and core values. Our rich diversity makes us more innovative and more creative, which helps us better serve our clients and our communities. Read more here ( Employment Opportunity Statement
Accenture is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation.
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Accenture is committed to providing veteran employment opportunities to our service men and women.
For details, view a copy of the Accenture Equal Employment Opportunity and Affirmative Action Policy Statement ( .
Requesting An Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs for a disability or religious observance, please call us toll free at 1 ( , send us an email ( or speak with your recruiter.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
View Now
0
Manufacturing Process Engineer II
46202 Indianapolis, Indiana
Danaher Corporation
Posted today
Job Viewed
Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System ( which makes everything possible.
The Manufacturing Process Engineer II is responsible for supporting process engineering activities for the Indianapolis Site for Life Science Products. This person will support efforts to resolve product and/or process technical issues impacting product quality and delivery. Responsible for solving complex issues in a production environment through structured problem solving and development / implementation of solutions that meet quality and production goals while adhering to company procedures and industry and regulatory standards. Technical skills should include PFMEA, process capability & other statistical methods relevant to manufacturing processes, data analysis, problem solving methodologies (Six Sigma, 5 Why, 8-D), reliability, and error proofing.
This position reports to the Sr. Manager, Manufacturing/Process Engineering and is part of the Beckman Coulter Life Science Manufacturing located in Indianapolis, IN and will be an on-site role.
In this role, you will have the opportunity to:
+ Provide sustaining engineering support for Beckman Coulter Life Science products produced at the Indianapolis Site (Particle Characterization, Centrifuge, and Liquid Handling Automation)
+ Responsible for the completion of mechanical design projects from conception, definition, design, and release to production targeted to resolve product design issues impacting external customer quality, operational metrics (delivery, yield, cost), and other product change drivers (regulatory, feature enhancements, etc.)
+ Responsible for leading and supporting design change team activities in order to document and implement design changes in compliance with design control procedures
The essential requirements of the job include:
+ Bachelor Degree in Mechanical Engineering or Mechanical Engineering Technology with 2+ years experience in product development and product engineering support role or Master's Degree with experience.
+ Experience with instrumentation (equipment) design and integration including complex electro-mechanical systems, fluid handling, pneumatics, thermal systems, and/or optical systems.
+ Proficiency in using SolidWorks (Surface Modeling, Motion, and simulation), Performing Tolerance Analysis, and GD&T
+ Demonstrated capability to troubleshoot and improve mechanical and electromechanical systems using formal problem-solving methodology with analytical and statistical methods.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to lift, move or carry equipment up to 50lb
It would be a plus if you also possess previous experience in:
+ Experience in dealing with design changes in a structured design control/change environment for medical devices
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ( .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System ( which makes everything possible.
The Manufacturing Process Engineer II is responsible for supporting process engineering activities for the Indianapolis Site for Life Science Products. This person will support efforts to resolve product and/or process technical issues impacting product quality and delivery. Responsible for solving complex issues in a production environment through structured problem solving and development / implementation of solutions that meet quality and production goals while adhering to company procedures and industry and regulatory standards. Technical skills should include PFMEA, process capability & other statistical methods relevant to manufacturing processes, data analysis, problem solving methodologies (Six Sigma, 5 Why, 8-D), reliability, and error proofing.
This position reports to the Sr. Manager, Manufacturing/Process Engineering and is part of the Beckman Coulter Life Science Manufacturing located in Indianapolis, IN and will be an on-site role.
In this role, you will have the opportunity to:
+ Provide sustaining engineering support for Beckman Coulter Life Science products produced at the Indianapolis Site (Particle Characterization, Centrifuge, and Liquid Handling Automation)
+ Responsible for the completion of mechanical design projects from conception, definition, design, and release to production targeted to resolve product design issues impacting external customer quality, operational metrics (delivery, yield, cost), and other product change drivers (regulatory, feature enhancements, etc.)
+ Responsible for leading and supporting design change team activities in order to document and implement design changes in compliance with design control procedures
The essential requirements of the job include:
+ Bachelor Degree in Mechanical Engineering or Mechanical Engineering Technology with 2+ years experience in product development and product engineering support role or Master's Degree with experience.
+ Experience with instrumentation (equipment) design and integration including complex electro-mechanical systems, fluid handling, pneumatics, thermal systems, and/or optical systems.
+ Proficiency in using SolidWorks (Surface Modeling, Motion, and simulation), Performing Tolerance Analysis, and GD&T
+ Demonstrated capability to troubleshoot and improve mechanical and electromechanical systems using formal problem-solving methodology with analytical and statistical methods.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to lift, move or carry equipment up to 50lb
It would be a plus if you also possess previous experience in:
+ Experience in dealing with design changes in a structured design control/change environment for medical devices
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ( .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
View Now
1
Scientist - API Manufacturing Process Support
46202 Indianapolis, Indiana
Lilly
Posted today
Job Viewed
Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
**Responsibilities:**
+ Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
+ Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
+ Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
+ Develop and monitor established metrics in real-time to assess process variability and capability.
+ Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
+ Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
+ Provide support internal and joint process teams and to the global and local PLOT teams.
+ Ability to independently set up and execute various chemical reactions.
+ Ensure that experiments are well designed with clear objectives.
+ Ability to analyze data and ensure appropriate documentation.
+ Utilize save laboratory practice and adhere to CHP requirements.
+ Write technical reports and documents.
**Basic Requirements:**
+ Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
**or**
+ Master's Degree and 1 year experience in cGMP manufacturing.
**Additional Preferences:**
+ Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
+ Demonstrated basic knowledge in small or large molecule API Manufacturing.
+ Familiarity with cGMP manufacturing environment and terminology.
+ Excellent analytical, interpersonal, written and oral communication skills.
+ Ability to work independently as well as part of a team.
+ Ability to prioritize activities.
+ Good judgment and flexibility.
**Additional Information:**
+ Tasks require entering manufacturing areas which require wearing appropriate PPE.
+ Domestic and international Travel (variable, can approach 20%).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
**Responsibilities:**
+ Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
+ Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
+ Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
+ Develop and monitor established metrics in real-time to assess process variability and capability.
+ Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
+ Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
+ Provide support internal and joint process teams and to the global and local PLOT teams.
+ Ability to independently set up and execute various chemical reactions.
+ Ensure that experiments are well designed with clear objectives.
+ Ability to analyze data and ensure appropriate documentation.
+ Utilize save laboratory practice and adhere to CHP requirements.
+ Write technical reports and documents.
**Basic Requirements:**
+ Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
**or**
+ Master's Degree and 1 year experience in cGMP manufacturing.
**Additional Preferences:**
+ Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
+ Demonstrated basic knowledge in small or large molecule API Manufacturing.
+ Familiarity with cGMP manufacturing environment and terminology.
+ Excellent analytical, interpersonal, written and oral communication skills.
+ Ability to work independently as well as part of a team.
+ Ability to prioritize activities.
+ Good judgment and flexibility.
**Additional Information:**
+ Tasks require entering manufacturing areas which require wearing appropriate PPE.
+ Domestic and international Travel (variable, can approach 20%).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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2
Contract Manufacturing Sr. Process Engineer - Indy Device Manufacturing
46202 Indianapolis, Indiana
Lilly
Posted today
Job Viewed
Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The position is responsible for working with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to provide process engineering support to operations, product supply, quality, and deliver continuous process improvement of delivery devices, sub-assemblies, and components that are supplied to Lilly packaging and manufacturing sites.
- Provide technical engineering oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
- Lead prioritization of process changes necessary to maintain, sustain and improve the manufacturing process.
- Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
- Develop effective and productive working relationships with colleagues at CM sites.
- Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability.
- Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
- Manage and coordinate shutdown scope activities at CM sites and ensure on-time Return to Service.
- Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab-based testing, documentation of the data and completion of technical reports. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested.
- Define and mitigate technical and patient risks, including the use of FMEA/pFMEA.
- Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
- Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
- Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
- Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
**Minimum Experience Qualification Requirements:**
- Minimum 3 years engineering experience, preferably in Manufacturing
- Demonstrated high degree of ownership / accountability
- Strong communication, teamwork, and networking skills
- Mechanical aptitude
- Solid technical writing skills
- Proven ability to organize and prioritize multiple tasks
- Strong attention to detail
- Proven problem solving skills
- Ability to work independently as well as in a team environment
**Additional Preferences:**
- Medical Devices experience preferred
- Experience with DOE and statistical methods as applied to engineering studies and reports
- Experience in capital project delivery and project management processes
**Minimum Education Requirements:**
BS in an Engineering or Engineering related field
**Other Information (e.g., any required certifications):**
Ability to participate in a short-term assignment (STA) for 6 to 12 months.
After STA, ability to travel 25% on average with peak over 50% for up to few months at a time
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
The position is responsible for working with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to provide process engineering support to operations, product supply, quality, and deliver continuous process improvement of delivery devices, sub-assemblies, and components that are supplied to Lilly packaging and manufacturing sites.
- Provide technical engineering oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
- Lead prioritization of process changes necessary to maintain, sustain and improve the manufacturing process.
- Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
- Develop effective and productive working relationships with colleagues at CM sites.
- Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability.
- Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
- Manage and coordinate shutdown scope activities at CM sites and ensure on-time Return to Service.
- Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab-based testing, documentation of the data and completion of technical reports. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested.
- Define and mitigate technical and patient risks, including the use of FMEA/pFMEA.
- Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
- Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
- Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
- Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
**Minimum Experience Qualification Requirements:**
- Minimum 3 years engineering experience, preferably in Manufacturing
- Demonstrated high degree of ownership / accountability
- Strong communication, teamwork, and networking skills
- Mechanical aptitude
- Solid technical writing skills
- Proven ability to organize and prioritize multiple tasks
- Strong attention to detail
- Proven problem solving skills
- Ability to work independently as well as in a team environment
**Additional Preferences:**
- Medical Devices experience preferred
- Experience with DOE and statistical methods as applied to engineering studies and reports
- Experience in capital project delivery and project management processes
**Minimum Education Requirements:**
BS in an Engineering or Engineering related field
**Other Information (e.g., any required certifications):**
Ability to participate in a short-term assignment (STA) for 6 to 12 months.
After STA, ability to travel 25% on average with peak over 50% for up to few months at a time
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
View Now
3
Associate Director - Small Molecule Process Manufacturing Quality - Lilly Medicine Foundry
46202 Indianapolis, Indiana
Lilly
Posted today
Job Viewed
Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Overview:**
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly's largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026.**
**Position Summary:**
The Small Molecule facility is responsible for the manufacture of drug substance (DS) produced via organic synthesis, which includes traditional small molecule medicines at multiple scales as well as high potency antibody drug conjugates.
Associate Director for Small Molecule Process Quality will lead the team responsible for quality oversight of the operations in the Small Molecule facility. The role is also responsible for participating as a cross-functional management team member that provides functional support to Small Molecule operations in meeting the site's operational plan? This role will be responsible for supporting quality management processes for the Small Molecule facility including review and approval of deviations, change controls, and other records requiring Quality approval. This role will be key to ensuring a strong quality culture and establishing a safety, quality and continuous improvement focused mindset within the Quality team supporting the Small Molecule facility and the broader organization?
As the Foundry is currently in design and construction, this position will provide Quality oversight as quality and digital processes are designed, developed, and implemented. This position is responsible for monitoring capacity and allocating Quality representatives to provide sufficient support and the project schedule remains on track.
**Responsibilities & Scope:**
+ Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
+ Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent.
+ Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
+ Support the execution of the site operational readiness plan including development of quality processes and approval of operational procedures and controls
+ Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
+ Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
+ Work cross-functionally with the plant teams for metrics reviews, operational support, and issue management
+ Define and execute inspection readiness activities
+ Forecast resource needs across the integrated plan and anticipating and resolving any projected resource issues before they impact project delivery.
+ Facilitate decision making within the team under tight deadlines.
+ Effectively communicate and manage internal and external stakeholders.
+ Participate in global communities of practice and committees as appropriate to establish and maintain a network for benchmarking and shared learning.
+ Identify and lead process improvement projects impacting multiple business areas.
**Basic Qualifications:**
+ BA/BS degree in the Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferred.
+ Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
+ Strong knowledge of the current GMP expectations and application of quality management systems in execution.
**Additional Preferences:**
**Demonstration of the following:**
+ Experience providing quality oversight for facilities manufacturing clinical and/or commercial drug substance. Experience in synthetic molecule API manufacturing is beneficial.
+ Project management and delivery of medium to large cross-functional initiatives.
+ Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
+ Ability to input and influence decision making for complex technical issues.
+ Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
+ Experience with networking across industry, such as with industry groups or committees.
+ Success in coaching, developing personnel, and mentorship.
+ Ability to establish key relationships and influence peers and business partners.
+ Strong communication skills.
+ Ability to identify and prioritize issues, develop, and implement solutions.
+ High learning agility and ability to deal with ambiguity, uncertainty.
+ Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $191,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
**Overview:**
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly's largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026.**
**Position Summary:**
The Small Molecule facility is responsible for the manufacture of drug substance (DS) produced via organic synthesis, which includes traditional small molecule medicines at multiple scales as well as high potency antibody drug conjugates.
Associate Director for Small Molecule Process Quality will lead the team responsible for quality oversight of the operations in the Small Molecule facility. The role is also responsible for participating as a cross-functional management team member that provides functional support to Small Molecule operations in meeting the site's operational plan? This role will be responsible for supporting quality management processes for the Small Molecule facility including review and approval of deviations, change controls, and other records requiring Quality approval. This role will be key to ensuring a strong quality culture and establishing a safety, quality and continuous improvement focused mindset within the Quality team supporting the Small Molecule facility and the broader organization?
As the Foundry is currently in design and construction, this position will provide Quality oversight as quality and digital processes are designed, developed, and implemented. This position is responsible for monitoring capacity and allocating Quality representatives to provide sufficient support and the project schedule remains on track.
**Responsibilities & Scope:**
+ Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
+ Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent.
+ Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
+ Support the execution of the site operational readiness plan including development of quality processes and approval of operational procedures and controls
+ Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
+ Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
+ Work cross-functionally with the plant teams for metrics reviews, operational support, and issue management
+ Define and execute inspection readiness activities
+ Forecast resource needs across the integrated plan and anticipating and resolving any projected resource issues before they impact project delivery.
+ Facilitate decision making within the team under tight deadlines.
+ Effectively communicate and manage internal and external stakeholders.
+ Participate in global communities of practice and committees as appropriate to establish and maintain a network for benchmarking and shared learning.
+ Identify and lead process improvement projects impacting multiple business areas.
**Basic Qualifications:**
+ BA/BS degree in the Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferred.
+ Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
+ Strong knowledge of the current GMP expectations and application of quality management systems in execution.
**Additional Preferences:**
**Demonstration of the following:**
+ Experience providing quality oversight for facilities manufacturing clinical and/or commercial drug substance. Experience in synthetic molecule API manufacturing is beneficial.
+ Project management and delivery of medium to large cross-functional initiatives.
+ Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
+ Ability to input and influence decision making for complex technical issues.
+ Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
+ Experience with networking across industry, such as with industry groups or committees.
+ Success in coaching, developing personnel, and mentorship.
+ Ability to establish key relationships and influence peers and business partners.
+ Strong communication skills.
+ Ability to identify and prioritize issues, develop, and implement solutions.
+ High learning agility and ability to deal with ambiguity, uncertainty.
+ Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $191,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
View Now
4
MFG PLANT SENIOR OPERATIONS LEADER
46262 Indianapolis, Indiana
Kroger
Posted 3 days ago
Job Viewed
Job Description
Job DescriptionSupervise and control all planning, coordination and direction of production activities, ensuring maximum operating efficiency and product quality. Develop operations resource leaders to maintain and improve plant performance. Perform all jobs safely, efficiently and accurately to maintain and improve the performance of the entire plant in the areas of Safety, Quality, Reliability (SQR) and our Customer 1st strategy. Provide leadership that embodies our 7 Kroger Manufacturing High Performance Work System principles. Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion and safety.Responsibilities- Maintain and communicate awareness of industry trends, including new developments in equipment, ingredients and customer needs- Support and participate in the plant safety process- Apply analysis and knowledge of plant processing and operations to develop and maintain department structure to satisfy production needs and objectives- Advance recommendations on policies, procedures, techniques, facilities, production planning and all other matters related to effective plant and department operations- Prepare production portion of operating budgets; implement and control approved budgets- Communicate effectively with plant leadership to ensure efficient and timely policy implementation- Communicate and coordinate responsibilities with all plant supervisory staff, including maintenance, sanitation, quality control and the plant office- Maintain close contact with sales and marketing activity, keeping abreast of all sales and marketing activities that may affect production distribution- Develop and implement methods for enabling all employees to achieve plant production goals- Develop department managers and associates to the fullest extent of their ability, while maintaining positive engagement- Follow established programs, policies and practices to produce safe, quality foods that meet regulatory and company requirements- Accountable to the Kroger Manufacturing Food Safety and Quality Principles- Supervise and coach direct reports in the performance of their duties; complete performance reviews and provide feedback to direct reports- Must be able to perform the essential job functions of this position with or without reasonable accommodation- Must be able to work around ingredients and/or finished products known to contain food allergensQualifications Minimum - Bachelor's Degree a related field supporting food manufacturing operations - 7+ years of experience in manufacturing operations - Proven leadership ability - Functional knowledge of Microsoft Office - Essential math skills - Must be highly organized and systematic in approach - Ability to comprehend complex oral and written instructions - Strong oral and written communication skills - Strong attention to detail, with a high degree of accuracy and precision - Thorough knowledge of plant operations and procedures Desired - Previous experience as superintendent or other mid-level management position in food manufacturing plant - Working knowledge of Total Process Control (TPC) or lean manufacturing practicesAbout UsFrom one tiny Cincinnati grocery store more than a century ago, we've grown into what today is the nation's largest grocer with nearly 2,800 stores in 35 states operating under 28 different names. As America's grocer, we take pride in bringing diverse teams with a passion for food and people together with one common purpose: To Feed the Human Spirit. With a history of innovation, we work tirelessly to create amazing experiences for our customers, communities AND each other, with food at the heart of it all. Here, people matter. That's why we strive to provide the ingredients you need to create your own recipe for success at work and in life. We help feed your future by providing the value and care you need to grow. If you're caring, purpose-driven and hungry to learn, your potential is unlimited. Whether you're seeking a part-time position or a new career path, we've got a fresh opportunity for you. Apply today to become part of our Kroger family! What you'll receive from us: The Kroger Family of Companies offers comprehensive benefits to support your Associate Well-Being, including Physical, Emotional, Financial and more. We'll help you thrive, with access to: A wide range of healthcare coverage, including affordable, comprehensive medical, dental, vision and prescription coverage, through company plans or collective bargaining agreement plans. Flexible scheduling in full- and part-time roles with paid time off, including holiday and sick pay based on eligibility and length of service. Emotional and financial support with free counseling through our Employee Assistance Program and free, confidential financial tools and coaching with Goldman Sachs Ayco. Valuable associate discounts on purchases, including food, travel, technology and so much more. Up to $21,000 in tuition reimbursement over your career, through our industry-leading Continuing Education program. Vast potential for growth, through an abundance of industry-leading training programs and diverse career pathways. For more information about benefits and eligibility, please visit our Benefits Page!
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5
Process Engineer - Device Contract Manufacturing
46202 Indianapolis, Indiana
Lilly
Posted today
Job Viewed
Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Responsibilities:**
+ Provide technical engineering oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
+ Lead prioritization of process changes crucial to maintain, sustain and improve the manufacturing process.
+ Coordinate/lead multi-functional/cross-site/cross-company engineering project teams as needed.
+ Develop effective and productive working relationships with colleagues at CM sites.
+ Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability.
+ Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
+ Lead and coordinate shutdown scope activities at CM sites and ensure on-time Return to Service.
+ Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested.
+ Define and mitigate technical and patient risks, including the use of FMEA/pFMEA.
+ Support the completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
+ Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
+ Assist on Commercialization project teams for new devices with focus on manufacturing readiness.
+ Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
**Basic Qualifications:**
+ Bachelors in Engineering or technical related field (mechanical engineering preferred
+ Minimum 2 years of manufacturing engineering experience (pharmaceutical/medical device experience preferred, open to other industries) ?
**Additional Preferences:**
+ Medical Devices experience preferred
+ Experience with DOE and statistical methods as applied to engineering studies and reports
+ Experience in capital project delivery and project management processes
+ Demonstrated high degree of ownership / accountability
+ Strong communication, teamwork, and networking skills
+ Mechanical proficiency
+ Solid technical writing skills
+ Ability to organize and prioritize multiple tasks
+ Strong attention to detail
+ Proven problem-solving skills
+ Ability to work independently as well as in a team environment
**Additional Information:**
+ Ability to travel 25% on average with peak over 50% at times.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $143,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Responsibilities:**
+ Provide technical engineering oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
+ Lead prioritization of process changes crucial to maintain, sustain and improve the manufacturing process.
+ Coordinate/lead multi-functional/cross-site/cross-company engineering project teams as needed.
+ Develop effective and productive working relationships with colleagues at CM sites.
+ Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability.
+ Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
+ Lead and coordinate shutdown scope activities at CM sites and ensure on-time Return to Service.
+ Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested.
+ Define and mitigate technical and patient risks, including the use of FMEA/pFMEA.
+ Support the completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
+ Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
+ Assist on Commercialization project teams for new devices with focus on manufacturing readiness.
+ Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
**Basic Qualifications:**
+ Bachelors in Engineering or technical related field (mechanical engineering preferred
+ Minimum 2 years of manufacturing engineering experience (pharmaceutical/medical device experience preferred, open to other industries) ?
**Additional Preferences:**
+ Medical Devices experience preferred
+ Experience with DOE and statistical methods as applied to engineering studies and reports
+ Experience in capital project delivery and project management processes
+ Demonstrated high degree of ownership / accountability
+ Strong communication, teamwork, and networking skills
+ Mechanical proficiency
+ Solid technical writing skills
+ Ability to organize and prioritize multiple tasks
+ Strong attention to detail
+ Proven problem-solving skills
+ Ability to work independently as well as in a team environment
**Additional Information:**
+ Ability to travel 25% on average with peak over 50% at times.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $143,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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