Pharma PM - Manufacturing Systems

27520 Selma, North Carolina Insight Global

Posted 19 days ago

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Job Description

Responsibilities: * Lead IT projects within the pharmaceutical manufacturing environment, ensuring successful delivery and implementation. * Collaborate with cross-functional teams to define project scope, goals, and deliverables that support business objectives. * Develop full-scale project plans and associated communication documents. * Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion. * Estimate the resources and participants needed to achieve project goals. * Draft and submit budget proposals, recommend subsequent budget changes where necessary. * Plan, schedule, and track project timelines, milestones, and deliverables using appropriate tools. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to com. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: . Requirements: * Proven experience as a Project Manager within IT or automation in manufacturing or production environments. o Pharmaceutical highly preferred * A minimum of 2 years of direct work experience in a project management capacity. * Practical knowledge of process automation systems such as DeltaV and Syncade preferred. * Bachelors degree in Engineering or related field * Ability to lead projects from conception to completion within tightly prescribed timelines. * Exceptional written and oral communication skills.

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Manufacturing Supervisor I- Purification

27528 Clayton, North Carolina Grifols Shared Services North America, Inc

Posted 2 days ago

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Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Shift: 12 Hour Rotating**
**Summary:**
The Manufacturing Supervisor is responsible for a Manufacturing department's day to day operations to ensure the manufacture of products are within cGMP, safety regulations and policies and procedures. This is an entry level Supervisor role. Provides routine technical support and makes decisions within a well defined area of responsibility.
**Primary Responsibilities for role (level specific responsibilities should be included in the chart below):**
+ Directs shift operations and ensures product integrity in accordance with the production schedule, cGMP, safety regulations and policies & procedures.
+ Maintains floor presence to minimize discrepancies and promote process compliance and accurate documentation.
+ Participates in process/product troubleshooting in order to correct/maintain desirable process parameter.
+ Acts as an initial point of contact for partner groups (i.e. Maintenance, Quality, Tech Doc Support, etc.) Research and address simple process deviations, documentation errors, etc.
+ Qualified to operate all equipment and lead processes to ensure the production schedule is met.
+ May recommend and with direction, implement measures to improve production methods, equipment performance, facility layout and quality of product.
+ Manage employees performance, coach and counsel for development.
+ Ensures required training for employee is achieved, effective and timely.
+ Makes decisions independently, but within a well-defined area.
+ Sought for counsel within field of expertise.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and/or supervisors may assign other duties as needed.
**Knowledge, Skills and Abilities**
+ Ability to communicate effectively at all levels of the organization.
+ Ability to lead teams and promote a positive and thriving team environment.
+ Ability to troubleshoot and provide sound solutions for complex process related matters. .
**Education:**
+ BA/BS degree + 2 years related experience.
+ Masters degree + 0 years
**Experience:**
+ Previous leadership experience preferred.
*Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:** 530833
**Type:** Regular Full-Time
**Job Category:** Manufacturing
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Quality Control Process Technical Analyst

27528 Clayton, North Carolina Novo Nordisk

Posted 8 days ago

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About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
+ Leading pay and annual performance bonus for all positions
+ All employees enjoy generous paid time off including 14 paid holidays
+ Health Insurance, Dental Insurance, Vision Insurance - effective day one
+ Guaranteed 8% 401K contribution plus individual company match option
+ Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
+ Free access to Novo Nordisk-marketed pharmaceutical products
+ Tuition Assistance
+ Life & Disability Insurance
+ Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Provides support to Quality Control (QC) by driving continuous improvement, optimization, and innovation as well as leading systematic problem solving and change requests. Works with members of the departmental leadership team to share best practices with NN departments/sites & external vendors. Based on assigned area of responsibility, may work with LIMS and/or QC initiatives.
Relationships
Reports to Manager, QC Support.
Essential Functions
+ Serve as QC Global LIMS Site SuperUser and QC Static Builder responsible for training and building of QC methods
+ Responsible for driving continuous improvement, innovation, and optimization projects
+ Responsible for driving change requests and assisting with large scale investigations (QMT)
+ Lead & coach peer analysts and leaders in problem solving for small-scale process & quality issues
+ Understand the processes of data evaluation and trending, to include reporting findings to leadership
+ Represent QC on global level and interact/collaborate with other NN sites
+ Follow all safety & environmental requirements in the performance of duties
+ Other accountabilities, as assigned
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Qualifications
+ Bachelor's degree in science or technical field from an accredited university required or equivalent combination of education and experience required
+ May consider an associate degree in science or technical field from an accredited university required with a minimum of seven (7) years QC experience
+ Minimum of five (5) years of QC experience in a pharmaceutical or related (regulated) environment required
+ Leadership/Supervisory experience preferred
+ Demonstrated foundational understanding of processes, procedures & products associated with assigned areas required
+ Perform detailed analysis of events & processes, develop appropriate responses to situational needs, & convey information/results to various organizational levels as appropriate required
+ Demonstrated knowledge of adult learning methodologies & can use multiple methods to train & coach others within the department & organization preferred
+ Knowledge & understanding regarding departmental processes & their high-level inter-relationships required (i.e. how they work together to establish a system)
+ Excellent verbal & written communication skills, investigative writing skills, & computer skills (MS Word, Outlook, Excel, PowerPoint, & LIMS) required
+ Demonstrates ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1- . This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Quality Control Validation Area Specialist I

27528 Clayton, North Carolina Novo Nordisk

Posted 10 days ago

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Job Description

About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
+ Leading pay and annual performance bonus for all positions
+ All employees enjoy generous paid time off including 14 paid holidays
+ Health Insurance, Dental Insurance, Vision Insurance - effective day one
+ Guaranteed 8% 401K contribution plus individual company match option
+ Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
+ Free access to Novo Nordisk-marketed pharmaceutical products
+ Tuition Assistance
+ Life & Disability Insurance
+ Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.
Relationships
Reports to Manager.
Essential Functions
+ Accuracy & compliance of validation & equipment records
+ Validation responsible for QC equipment & instrumentation
+ Identify & handle deviations per proper appropriate procedures
+ Maintain good standing with stakeholders through engagement & positive cooperation
+ Perform & oversee change control activities for QC equipment & systems
+ Follow all safety and environmental requirements in the performance of duties
+ Other accountabilities, as assigned
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Qualifications
+ Bachelor's Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
+ May consider Associate's Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
+ Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
+ Experience in writing & executing validation protocols preferred
+ Experience in managing projects preferred
+ Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
+ Working knowledge of GMPs required
+ Ability to act as project manager driving & implementing equipment projects required
+ Demonstrated ability to write & present technical/scientific documents & reports preferred
+ Understanding of QC equipment/systems, end user functionality & life-cycle management a plus
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1- . This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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NFF Manufacturing Supervisor I (Night Shift)

27528 Clayton, North Carolina Grifols Shared Services North America, Inc

Posted 1 day ago

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Job Description

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**NFF-Manufacturing Supervisor / Manufacturing Supervisor II**
The Manufacturing Supervisor is responsible for demonstrating consistent application of technical and/or regulatory knowledge, supervising a team of technicians, executing assignments of medium complexity, and developing solutions for defined problems. Trains others at the entry level.
**Primary Responsibilities for the Supervisor Role:**
+ Sought for counsel within field of expertise.
+ Makes decisions with designated assignments that influence the goals of the department.
+ Produces anticipated results that contribute to business or technical goals.
+ Develops alternative solutions to problems, handles complex problems independently.
+ Displays flexibility with assignments in different units/plants
+ Demonstrates strong technical and/or regulatory expertise and ability to adapt to changing circumstances.
+ Displays flexibility with assignments in different units/plants
+ Manages employee performance (i.e. conducts annual performance reviews)
+ Researches and addresses process deviations, documentation errors, ITS', etc.
+ Trains less experienced employees.
+ Ensures product integrity through enforcing compliance with all cGMP's and personnel safety through enforcement of site policies and rules.
**Primary Responsibilities for the Supervisor II Role:**
In addition to the above mastered responsibilities of the Supervisor you will also be responsible for the following:
+ Leads the planning and organization of specific job assignments.
+ Contributes to budget development/adherence in defined areas.
+ Coaches and teaches less experienced members of the department and provides input to performance evaluations.
+ Meets customer needs in support of business goals.
+ Resolves conflicts within area of responsibility.
+ Demonstrates the ability to compromise and reach consensus in areas of responsibility.
+ Begins to manage balance between technical and management issues using multiple skill sets (analyzing, evaluating, creating, reasoning and reaching conclusion) and can meet changing priorities.
+ Conforms to established company beliefs and values with integrity.
+ Promotes regulatory compliance.
+ Ensures personnel safety.
**Location: Clayton, NC- NFF**
**Shift: 1900-0700, Rotating nights**
**Requirements:**
**Supervisor** : BA/BS Degree, plus a minimum of 4 years' experience OR Master's Degree plus a minimum of 2 years' experience, OR a PhD plus a minimum of 0 years' experience. Previous Supervisor Experience Required.
**_Depending on the area of assignment, directly related experience or a combination of directly related education and experience._**
**_Supervisor II_** _: BA/BS Degree, plus a minimum of 6 years' experience OR Master's Degree plus a minimum of 0-4 years' experience, OR a PhD plus a minimum of 0-2 years' experience. Previous Supervisor Experience Required._
**_Depending on the area of assignment, directly related experience or a combination of directly related education and experience._**
_Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups._
_EEO Minorities/Women/Disabled/Veterans_
CLK78
**Location:** **NORTH AMERICA : USA : NC-Clayton** **:** **USNC0002 - Clayton**
Learn more about Grifols ( ID:** 528594
**Type:** Regular Full-Time
**Job Category:** Manufacturing
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Digital Data & Analytics Manufacturing Execution Systems Project Leader

27597 Zebulon, North Carolina GSK LLP

Posted 3 days ago

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Job Description

The Digital Data & Analytics Manufacturing Execution Systems Project Leader will deploy MES systems as well as manage and maintain existing GSC Zebulon Manufacturing Execution Systems (MES), i.e. Electronic Batch Records, to support the business continuity and delivery of the company's 'Digital and Smart Manufacturing' ambition.

This role is directly involved in the delivery of the GSC Smart Manufacturing business imperative, using technology, data, and systems to transform the way we manufacture and supply, creating a reliable, resilient and agile supply chain, with a view to being an industry leading in smart manufacturing by 2030.

Deploy technical solutions across quality, manufacturing, maintenance and logistics operations, improving efficiency and reducing waste by identify opportunities, implement solutions and manage/improve those processes through modern/agile best practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Partner with GSK central functions and local departments, including GPS, PROD, ENG, MSAT and Finance to ensure alignment, prioritization and support of site DDA and Smart Automation programs
  • Lead the Deployment of MES Solutions across site by developing technical/business requirements, updating associated documentation, hardware installations, managing change control, leading validation testing, and conducting user training and cutover activities.
  • Build relationships with each function and global stakeholders to establish a robust communication process for effective delivery of requests and develop processes to efficiently implement changes into Production
  • Setup and facilitate a change forum to work with GPS, Production, MSAT, Quality, and Site IT to identify and implement continuous improvement
  • Manage deviations which cite MES systems as contributory cause or solution and attend CAPA selection sessions to support robust CAPA and highlight potential ineffective CAPA
  • Provide clear and effective communication of project to stakeholder, sound delivery of solutions that are on time and delivers business benefit.
  • Represent the MES team in Regulatory Inspections of systems
  • Maintain budgetary control - monitor and respond to risks / issues at the project and program level to ensure on time and in budget delivery
Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • 5+ years of experience in pharmaceutical industry
  • Experience in Incident management, Problem Solving and Change Management
  • Experience of Project Management of Technical Projects
  • Experience of systems/software development methodologies
  • Experience in a manufacturing environment
  • Experience with application design, testing and deployment of digital solutions in a GxP environment.
  • Experience with Data Integrity principals
  • Experience with Validated Computer Systems
Preferred Qualifications:
  • Bachelor's degree in Mathematics, Engineering, Computer Science or technical discipline
  • Business Process and Workflow Design, Document Mgmt, Experience in system software development methodologies
  • Is familiar with the concepts, standards, technology, tools,
  • processes, procedures, hardware, software and services in use for delivering technical solutions
  • Knowledge in Agile, Azure SQL, and Azure Data Lakes; Microsoft Power Platforms, Data Science
  • Knowledge and experience working with Six Sigma/Lean Sigma processes and tools.
  • Knowledge and experience supporting GxP and Sarbanes
  • Oxley regulated applications
  • Comprehensive knowledge and understanding of the Systems Development Life Cycle
  • Good knowledge and understanding of IT systems and how they apply to supported business areas.
  • Knowledge of systems/software development methodologies and system architectures
  • High learning agility - ability to learn and adapt to new concepts, systems, and software independently and quickly
  • Well-developed analytical and problem-solving skills
  • Strong relationship building and team working skills to influence and drive Business change
  • Must be able to work independently with minimal supervision
  • Experience at working within a cross functional team with proven collaboration, influencing and leadership skills
  • Full understanding of Good Manufacturing Practice in a Pharmaceutical Environment and EHS standards
  • Evidence of leading improvement activities with delivery of quantifiable business improvement
  • Expert competency in project work
  • Formal root causing and problem-solving techniques
  • Confident in own ability. Makes timely decisions in a confident way with justification if necessary. Ensures others are very clear about own stance or position when uncertainty exists
  • Ability to present technical concepts to end users as well as Senior level managers.


Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at
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Senior Director, People & Organization - Product Supply Aseptic Manufacturing

27520 Selma, North Carolina BioSpace, Inc.

Posted 3 days ago

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Job Description

Senior Director, People & Organization - Product Supply Aseptic Manufacturing 1 week ago Be among the first 25 applicants About The Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities responsible for different steps in our supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC, is a 457,000 sq ft aseptic "fill and finish" site producing injectable diabetes and obesity treatments. Join a global network of passionate manufacturing professionals. What We Offer You Leading pay and annual bonus Generous paid time off including 14 holidays Health, Dental, Vision Insurance from day one Guaranteed 8% 401K contribution + company match Family benefits: 14 weeks paid parental leave, 6 weeks family medical leave Free access to Novo Nordisk products Tuition Assistance, Life & Disability Insurance Referral awards and more The Position As part of the site leadership, you will oversee all people-related processes, organizational development, and training. Act as a trusted advisor to the VP and site leadership. Ensure world-class P&O processes, lead local training teams, and support site integration with greenfield expansion. Collaborate with US-based sites to develop and improve P&O policies across US manufacturing. Relationships Reports to VP of AM P&O. Key stakeholders include Site Leadership, US CMC-PS P&O heads, Centers of Excellence, and expansion teams. Essential Functions Translate business strategies into effective P&O plans Advise management, drive culture, engagement, organizational change, and talent development Lead projects to improve employee lifecycle processes Manage organizational integration for the Clayton greenfield project Support workforce planning and strategic staffing Oversee cross-site P&O policies, standards, and M&A support Build partnerships for employer branding and recruitment Ensure compliance with training and SOP documentation Uphold safety and environmental standards Physical Requirements Up to 10% travel; sitting, walking, standing; lift up to 10 lbs; effective communication skills Development of People Ensure individual development plans for staff, including learning and aspirations, aligned with business goals. Qualifications Bachelor’s in Business, HR, or related; Master’s preferred PHR or SPHR certification preferred Minimum 12 years HR experience, 5 years management, preferably in pharma manufacturing Knowledge of HR functions, employment law, mergers & acquisitions Strong leadership, stakeholder management, training, and communication skills Values-driven, strategic, collaborative, and inclusive mindset We are committed to diversity and inclusion. Qualified applicants will receive equal consideration regardless of background or characteristics. For accommodations, contact 1- . #J-18808-Ljbffr

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Digital Data & Analytics Manufacturing Execution Systems Project Leader

27597 Zebulon, North Carolina DaVita

Posted 3 days ago

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Job Description

Site Name: USA - North Carolina - Zebulon
Posted Date: Jun 13 2025

The Digital Data & Analytics Manufacturing Execution Systems Project Leader will deploy MES systems as well as manage and maintain existing GSC Zebulon Manufacturing Execution Systems (MES), i.e. Electronic Batch Records, to support the business continuity and delivery of the company's 'Digital and Smart Manufacturing' ambition.

This role is directly involved in the delivery of the GSC Smart Manufacturing business imperative, using technology, data, and systems to transform the way we manufacture and supply, creating a reliable, resilient and agile supply chain, with a view to being an industry leading in smart manufacturing by 2030.

Deploy technical solutions across quality, manufacturing, maintenance and logistics operations, improving efficiency and reducing waste by identify opportunities, implement solutions and manage/improve those processes through modern/agile best practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Partner with GSK central functions and local departments, including GPS, PROD, ENG, MSAT and Finance to ensure alignment, prioritization and support of site DDA and Smart Automation programs
  • Lead the Deployment of MES Solutions across site by developing technical/business requirements, updating associated documentation, hardware installations, managing change control, leading validation testing, and conducting user training and cutover activities.
  • Build relationships with each function and global stakeholders to establish a robust communication process for effective delivery of requests and develop processes to efficiently implement changes into Production
  • Setup and facilitate a change forum to work with GPS, Production, MSAT, Quality, and Site IT to identify and implement continuous improvement
  • Manage deviations which cite MES systems as contributory cause or solution and attend CAPA selection sessions to support robust CAPA and highlight potential ineffective CAPA
  • Provide clear and effective communication of project to stakeholder, sound delivery of solutions that are on time and delivers business benefit.
  • Represent the MES team in Regulatory Inspections of systems
  • Maintain budgetary control - monitor and respond to risks / issues at the project and program level to ensure on time and in budget delivery

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • 5+ years of experience in pharmaceutical industry
  • Experience in Incident management, Problem Solving and Change Management
  • Experience of Project Management of Technical Projects
  • Experience of systems/software development methodologies
  • Experience in a manufacturing environment
  • Experience with application design, testing and deployment of digital solutions in a GxP environment.
  • Experience with Data Integrity principals
  • Experience with Validated Computer Systems

Preferred Qualifications:

  • Bachelor's degree in Mathematics, Engineering, Computer Science or technical discipline
  • Business Process and Workflow Design, Document Mgmt, Experience in system software development methodologies
  • Is familiar with the concepts, standards, technology, tools,
  • processes, procedures, hardware, software and services in use for delivering technical solutions
  • Knowledge in Agile, Azure SQL, and Azure Data Lakes; Microsoft Power Platforms, Data Science
  • Knowledge and experience working with Six Sigma/Lean Sigma processes and tools.
  • Knowledge and experience supporting GxP and Sarbanes
  • Oxley regulated applications
  • Comprehensive knowledge and understanding of the Systems Development Life Cycle
  • Good knowledge and understanding of IT systems and how they apply to supported business areas.
  • Knowledge of systems/software development methodologies and system architectures
  • High learning agility - ability to learn and adapt to new concepts, systems, and software independently and quickly
  • Well-developed analytical and problem-solving skills
  • Strong relationship building and team working skills to influence and drive Business change
  • Must be able to work independently with minimal supervision
  • Experience at working within a cross functional team with proven collaboration, influencing and leadership skills
  • Full understanding of Good Manufacturing Practice in a Pharmaceutical Environment and EHS standards
  • Evidence of leading improvement activities with delivery of quantifiable business improvement
  • Expert competency in project work
  • Formal root causing and problem-solving techniques
  • Confident in own ability. Makes timely decisions in a confident way with justification if necessary. Ensures others are very clear about own stance or position when uncertainty exists
  • Ability to present technical concepts to end users as well as Senior level managers.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

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Talent Community - Heroes MAKE America Military to Manufacturing Career Fair

27529 Garner, North Carolina CBRE

Posted 10 days ago

Job Viewed

Tap Again To Close

Job Description

Talent Community - Heroes MAKE America Military to Manufacturing Career Fair
Job ID
182327
Posted
27-Aug-2024
Service line
GWS Segment
Role type
Full-time
Areas of Interest
Engineering/Maintenance, Facilities Management
Location(s)
Charlotte - North Carolina - United States of America, Concord - North Carolina - United States of America, Durham - North Carolina - United States of America, Fayetteville - North Carolina - United States of America, Garner - North Carolina - United States of America, Raleigh - North Carolina - United States of America, Smithfield - North Carolina - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
At **CBRE Global Workplace Solutions (GWS)** , Safety is our top priority! We maintain a safety-first culture in which CBRE employees return home in the same condition in which they reported to work. We're looking for skilled and forward-thinking Maintenance Technicians to join our growing team as we work to service one of the world's largest online retailers.
We offer competitive pay, a robust benefits package, wellness programs, and a workplace environment that committed to diversity. Join our global network of professionals supporting client operations across CBRE. Looking for growth and career advancement? We offer a path forward into management as an Area Maintenance Manager after 2 years of successful service!
Read on to learn more!
**About The Role**
In these vital roles, you will support the function of the client's Fulfillment Center (FC) operation, as a member of the Reliability Maintenance & Engineering (RME) team. As part of the RME team you will repair, maintain, and continuously improve functionality of materials handling equipment and robotic systems throughout the facility. Collaborating with the Operations team and other business partners, you will work behind the scenes to ensure optimal productivity for the site using industrial troubleshooting techniques, Predictive Maintenance (PdM) tools, and your maintenance knowledge to supervise and resolve equipment issues before they arise.
**What You'll do**
+ Repair, maintain, and continuously improve functionality of materials handling equipment (MHE) and robotic systems throughout the facility.
+ Lead and audit preventative maintenance procedures.
+ Install, maintain, and solve relay logic, ladder diagrams, control components, photo-eyes, motor starters, limit switches, proximity sensors, solenoids, etc.
+ Lead and mentor work plan for emergency repair of critical assets and training plans for Maintenance Technicians.
+ Build and close out work orders in a Computerized Maintenance Management System (CMMS).
+ Cultivate positive working relationships with RME business partners and Operations Maintenance team members.
+ Promote a safe working environment by following all safety procedures.
**What You'll Need**
**High School Diploma up to Bachelor's degree in Electrical or Mechanical Engineering, Engineering Technology, or other related engineering OR 5+ years of equivalent professional experience, depending on role.**
**Experience in mechanical, electrical, Computerized Maintenance Management System (CMMS), control network/HMI components, and Programmable Logic Controls (PLC) programs.**
**Physical requirements include stooping, standing, walking, climbing stairs / ladders and ability to lift / carry heavy loads of 50 lbs. or more.**
**CBRE Employee Benefits**
+ **Comprehensive medical, dental, vision**
+ **Disability benefit program**
+ **401k company matching**
+ **Paid time off and holidays**
+ **Company paid life insurance**
+ **Pet insurance**
+ **Paid parental leave**
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at +1 (U.S.) and +1 (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
View Now

Talent Community - Heroes MAKE America Military to Manufacturing Career Fair

27577 Smithfield, North Carolina CBRE

Posted 10 days ago

Job Viewed

Tap Again To Close

Job Description

Talent Community - Heroes MAKE America Military to Manufacturing Career Fair
Job ID
182327
Posted
27-Aug-2024
Service line
GWS Segment
Role type
Full-time
Areas of Interest
Engineering/Maintenance, Facilities Management
Location(s)
Charlotte - North Carolina - United States of America, Concord - North Carolina - United States of America, Durham - North Carolina - United States of America, Fayetteville - North Carolina - United States of America, Garner - North Carolina - United States of America, Raleigh - North Carolina - United States of America, Smithfield - North Carolina - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
At **CBRE Global Workplace Solutions (GWS)** , Safety is our top priority! We maintain a safety-first culture in which CBRE employees return home in the same condition in which they reported to work. We're looking for skilled and forward-thinking Maintenance Technicians to join our growing team as we work to service one of the world's largest online retailers.
We offer competitive pay, a robust benefits package, wellness programs, and a workplace environment that committed to diversity. Join our global network of professionals supporting client operations across CBRE. Looking for growth and career advancement? We offer a path forward into management as an Area Maintenance Manager after 2 years of successful service!
Read on to learn more!
**About The Role**
In these vital roles, you will support the function of the client's Fulfillment Center (FC) operation, as a member of the Reliability Maintenance & Engineering (RME) team. As part of the RME team you will repair, maintain, and continuously improve functionality of materials handling equipment and robotic systems throughout the facility. Collaborating with the Operations team and other business partners, you will work behind the scenes to ensure optimal productivity for the site using industrial troubleshooting techniques, Predictive Maintenance (PdM) tools, and your maintenance knowledge to supervise and resolve equipment issues before they arise.
**What You'll do**
+ Repair, maintain, and continuously improve functionality of materials handling equipment (MHE) and robotic systems throughout the facility.
+ Lead and audit preventative maintenance procedures.
+ Install, maintain, and solve relay logic, ladder diagrams, control components, photo-eyes, motor starters, limit switches, proximity sensors, solenoids, etc.
+ Lead and mentor work plan for emergency repair of critical assets and training plans for Maintenance Technicians.
+ Build and close out work orders in a Computerized Maintenance Management System (CMMS).
+ Cultivate positive working relationships with RME business partners and Operations Maintenance team members.
+ Promote a safe working environment by following all safety procedures.
**What You'll Need**
**High School Diploma up to Bachelor's degree in Electrical or Mechanical Engineering, Engineering Technology, or other related engineering OR 5+ years of equivalent professional experience, depending on role.**
**Experience in mechanical, electrical, Computerized Maintenance Management System (CMMS), control network/HMI components, and Programmable Logic Controls (PLC) programs.**
**Physical requirements include stooping, standing, walking, climbing stairs / ladders and ability to lift / carry heavy loads of 50 lbs. or more.**
**CBRE Employee Benefits**
+ **Comprehensive medical, dental, vision**
+ **Disability benefit program**
+ **401k company matching**
+ **Paid time off and holidays**
+ **Company paid life insurance**
+ **Pet insurance**
+ **Paid parental leave**
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at +1 (U.S.) and +1 (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
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