2,206 Manufacturing Specialist jobs in the United States

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a ( **Manufacturing Specialist** ), you are responsible for:
**Key Responsibilities:**
+ Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.
+ Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.
+ Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
+ Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc)
+ Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.
+ Participate in cross functional initiatives,
+ Adhere to department budget and all training, compliance, and safety requirements.
**Basic** **Qualifications:**
M.S. with 2+ years or BS with 4+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
**Preferred Qualifications:**
+ Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization
+ Experience supporting drug product manufacturing operations, technology transfer, and/or development. Prior experience with commercial manufacturing and/or process validation is highly desirable.
+ Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer.
+ Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines.
+ Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
+ Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing
+ Experience in cleaning process design, verification, and cross contamination strategies.
+ Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills
The salary range for this position is: $107,185.00 - $138,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

**Job Title** : Manufacturing Specialist
**Location:** Bloomington, MN.
**Shifts/Payrate:**
A Shift: 6:30 AM - 6:30 PM, M - W, every other TH ($20.00/hr.)
B Shift: 6:30 PM - 6:30 AM, M - W, every other TH ($2.50/hr.)
C Shift: 6:30 AM - 6:30 PM, F - SUN, every other TH ( 22.50/hr.)
D Shift: 6:30 PM - 6:30 AM, F - SUN, every other TH ( 23.00/hr.)
**Whats the job?**
- Be responsible for performing manufacturing operations to fabricate top-quality wafers for magnetic recording heads
- Operate assigned equipment to process or measure wafers
- Ensure procedures are followed and executed correctly
- Participate in ongoing training to learn new equipment and operations
- Communicate and collaborate with team members to ensure production flows smoothly
**Whats needed?**
- High School Diploma or GED.
-The ability to stand/walk around for 10+ hours
- Must be comfortable with wearing a cleanroom suit, facemask and gloves
- Flexibility to be able to move to weekend nights D Shift
- Language Fluency - English (Written & Verbal)
**Why should you choose Manpower?**
+ Free training to upgrade your skills, including a free college tuition program
+ Medical, dental, vision, 401k
+ Weekly pay with direct deposit
+ 24/7 Manpower customer care support
+ Dedicated Career Partner to help you achieve your career goals
+ Voted #1 best places to work by Glassdoor 2021
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

Manufacturing Specialist in Albuquerque, NM
Build your future at Curia, where our work has the power to save lives.
The Manufacturing Specialist is the lead person for operations and manufacturing (i.e., vial prep, isolator, fill line operation and vial sealing) of parenteral products according to Current Good Manufacturing Practice (cGMP) in an aseptic environment. This role will train, coach/develop, and provide timely feedback to team members. Responsibilities encompass: deliver production requirements, train operators to set up, operate, sanitize and sterilize equipment and manufacturing areas in a cleanroom setting. The Manufacturing Specialist ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The position also involves sanitizing aseptic and controlled areas using specialized solutions and equipment, following sanitization protocols during sterile processing of equipment, and complying with Standard Operating Procedures (SOPs) for all sanitization and documentation tasks.
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.
We proudly offer
+ Generous benefit options (eligible first day of employment)
+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)
+ Career advancement opportunities
+ Education reimbursement
+ 401K program with matching contributions
+ Learning platform
+ And more!
Essential Duties and Responsibilities:
+ Trains, coaches/develops, and provides timely feedback to team members
+ Represents Manufacturing in leadership meetings to support dedicated areas of responsibility
+ Revise SOPs and documents as needed
+ Drive activities and resolutions to improve process flow, safety, and overall production efficiency by identifying bottlenecks and fostering a culture of continuous improvement
+ Identify and resolve complex manufacturing issues through collaboration with quality, engineering, and technical operations management
+ Manages area of responsibility by ensuring compliance with cGMP standards, overseeing the proper operation and maintenance of equipment, and coordinating the sanitation and sterilization processes, as well as to maintain a controlled aseptic environment.
+ Ensures compliance with Drug Enforcement Administration (DEA) regulations during controlled substance formulations and verifies that staff adheres to these regulations.
+ Ensures the timely processing and proper execution of deviations, assessments, investigations & CAPA's
+ Manages the preparation and sterilization processes of equipment for clean rooms, product compounding, and filling according to the preparation list, to include disassembly and assembly
+ Responsible for checking the recordings entered by employees of all procedures in logbooks as well as confirm complete/correct batch records according to cGDP
+ Oversees the staff to complete the sanitization of aseptic/controlled production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces
+ Escalates issues/concerns in a timely manner as appropriate, to higher management
+ Cross-functional collaboration with all levels
+ Read/interpret SOPs to ensure compliance
+ Maintain up to date trainings
+ Other duties may be assigned
Education and Experience:
+ Bachelor's Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline
+ Prior experience in a fill/finish GMP and/or cleanroom, preferred
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
Computer Skills:
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
Other Skills and Abilities:
+ Ability to cultivate a culture of continuous improvement and right first-time quality
+ Fosters a collaborative and positive work environment
+ Champions change
+ Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
+ Demonstrates strong attention to detail
Other Qualifications:
+ Must pass a background check
+ Must pass a drug screen
+ May be required to pass Occupational Health Screening
+ Must be able to obtain and maintain gowning certification
+ Must be able to obtain and maintain media qualification
+ Must be able to wear a respirator
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

**Job Description Summary**
Engineering associated with the refurbish and remanufacturing process. Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Independent judgment may be required but guidance is available.
At GE HealthCare, our machine, our software, our solutions, our services, and our people make a genuine difference to medical professional, and patients all over the world. That's because we never lose sight of what healthcare really needs-the human touch.
**Job Description**
**Roles and Responsibilities**
+ Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.
+ In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
+ Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
+ A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members
+ Responsible for releasing new product to the floor including NPI (New Product Introduction) documentation.
+ Oversees the production process removing obstacles while ensuring compliance and driving improvements.
**Required Qualifications**
+ Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in service, manufacturing or remanufacturing)
**Desired Characteristics**
+ Strong oral and written communication skills. Ability to communicate in local language. (English)
+ Demonstrated ability to analyze and resolve problems.
+ Ability to document, plan, market, and execute programs.
+ Established project management skills.
#LI-SAM1
#LI-ONSITE
#LI-IN
**Additional Information**
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer ( . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** No

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.
**Job Summary:**
The Manufacturing Specialist (MES) will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have at least five years' experience in a pharmaceutical or biotech industry and will have demonstrated competency in a team environment to deliver results on time with project and commercial timelines.
+ Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
+ Responsible for leading MBR development design reviews including liaising with Operations, Process Validation and Quality functions and external functions such as Engineering, IT, R&D, other Grifols production sites as required.
+ Responsible for drafting, executing, and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
+ Responsible for the support and ongoing development of the Grifols Biologicals (GB) Operations MES system in development of MBRs and improving the MES business process.
+ Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
+ Responsible for the development, review, and update of MES Standard Operating Procedures.
+ Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner, Quality, etc.
+ Accountable for adherence to established timelines and metrics for the deviation, change control and CAPA process.
+ Responsible for providing technical support where required and as directed by Operations leadership
+ Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens PCS7, Wonderware. Werum, etc.
+ Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
+ Liaison with Grifols MES core-team to troubleshoot and develop new ways of working
**Knowledge, Skills and Abilities:**
+ Experience in database configuration and creation
+ Experience in pharmaceutical manufacturing and GMP
+ Working knowledge of operations in pharmaceutical/biotech industries or aseptic processing an advantage
+ Knowledge of regulation requirements (GMP& IT/System Integration, etc)
+ Experience with Osi Pi software
+ Experience with electronic batch records in a pharmaceutical environment
**Requirements and Education:**
+ Bachelor's degree in Engineering or Science or related industry qualification
+ Project Management Certification preferred
+ A minimum of 3+ years' experience in an operation's pharmaceutical environment.
**Occupational Demands** : Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 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 and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. 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. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues
The estimated pay scale for the Manufacturing Specialist role based in Los Angeles, CA, is $70,840 to $85,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
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 supervisors may assign other duties as needed.
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, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.**
California Personnel Privacy Policy and Notice at Collection
**Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA**
Learn more about Grifols ( ID:** 530137
**Type:** Regular Full-Time
**Job Category:** Maintenance / General Services / Facilities

**A Snapshot of Your Day**
You can expect working with teammates, in a safe, comfortable, climate-controlled environment, to manufacture parts for large generators. The primary purpose of this position is to build or make parts by crafting, forming, building various materials according to blueprints and instructions.
**How You'll Make an Impact**
+ Inspecting parts for quality achievement
+ Machine operation, including setup, adjustments
+ Use hand tools for building, forming, bending, punching, grinding, cutting, brazing, buffing, and welding. Use testing, electrical and measurement equipment. Lifting and loading parts and components to transport to various areas or machines
+ Use various solutions to apply to parts according to instructions. Use of appliances, such as ovens to bake and cure parts
+ Read blueprints, drawings, engineering specifications, and work package information to resolve operations required. Assembly and installation of parts according to instruction
+ Participate with all to keep the plant safe, organized, and clean, including cleaning your area daily. Complete employment requirements, such as passing a drug screen and background check
**What You Bring**
+ Education level preferred is a high school diploma or equivalent. Experience level is early professional, manufacturing experience is a plus but not required.
+ Able to read, write, and comprehend English language to understand instructions and other writings on the job description, follow warnings, safety and quality signage as well as writing communication when required on work instructions or sharing to team
+ May be required to take Work Keys assessment, with some positions requiring a minimum score or better.
+ Frequent mental and visual attention, where the flow of work is intermittent, or the operation involves waiting for the next process.
+ Good judgment and comprehension to plan, perform, follow written and verbal instructions and make decisions as to the building, quality inspection, manipulating and the counting of parts, operations, and processes within the limitations of recognized or standard methods and procedures.
+ Applicants must be legally authorized for employment in the United States without need for current or future employer-sponsored work authorization. Siemens Energy employees with current visa sponsorship may be eligible for internal transfers.
**About the Team**
**Gas Services**
Our Gas Services division offers Low-emission power generation through service and decarbonization. Zero or low emission power generation and all gas turbines under one roof, steam turbines and generators. Decarbonization opportunities through service offerings, modernization, and digitalization of the fleet.
Check out this video to learn more about our Gas Service business is Siemens Energy?**
At Siemens Energy, we are more than just an energy technology company. With ~100,000 dedicated employees in more than 90 countries, we develop the energy systems of the future, ensuring that the growing energy demand of the global community is met reliably and sustainably. The technologies created in our research departments and factories drive the energy transition and provide the base for one sixth of the world's electricity generation.
Our global team is committed to making sustainable, reliable, and affordable energy a reality by pushing the boundaries of what is possible. We uphold a 150-year legacy of innovation that encourages our search for people who will support our focus on decarbonization, new technologies, and energy transformation.
Find out how you can make a difference at Siemens Energy: Career growth and development opportunities
+ Supportive work culture and a healthy work-life balance
+ Competitive total rewards package
+ Parental leave
+ Profit sharing
+ Comprehensive health and wellness benefits, including insurance plans and virtual care
+ Financial security through 401K with company match and disability plans
+ Employee programs for mental health, financial bonuses, and service recognition
** Employment Opportunity Statement
Siemens Energy is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local
law.

**Job Description Summary**
GE Aerospace is a leader in the industrialization of ceramic matrix composites (CMCs) for the manufacture of military and commercial jet engines. CMC's are a technological breakthrough in advanced materials that enables a revolutionary change in the engine's fuel efficiency, performance and emissions through lower density and fuel burn at increased temperature. GEA's commitment to the development of CMC technology began in 2001 and has reached realization in 2016 with first deliveries of the LEAP engine for commercial narrow body airliners. Orders for LEAP, which features a CMC shroud component, have now reached 40,000 in number, reflecting the success of this product. GEA's commitment to the implementation of CMC technology continues with the GE9X engine, the first commercial engine to incorporate multiple CMC components. The first flight powered by GE9X engines was completed in January of 2020. These examples are just the beginning for the opportunities that CMC's create to transform the aviation industry and GEA is positioned to play a lead role in that revolution.
The Lead Manufacturing Specialist will utilize Flight Deck Principles to drive operational discipline for the GE Aerospace Huntsville site where SiC Fiber based Prepreg is produced. In this role, the employee is expected to develop & drive standard work that can be used to provide operational excellence relative to safety, quality, delivery, and cost. The ideal candidate will have a strong background in operations management, a keen eye for detail, and a passion for fostering a culture of excellence.
**Job Description**
**Roles and Responsibilities**
+ Analyze current operational processes and identify areas for improvement
+ Develop & drive standard work to ensure operational discipline in all areas of PSM Compliance & Conduct of Operations, including Product Traceability
+ Develop and implement standard work processes to ensure consistency, quality, and traceability
+ Drive operational discipline by ensuring adherence to established processes and standards
+ Collaborate with cross-functional teams to drive process improvements and achieve operational goals within the Tape Plant.
+ Foster a culture of continuous improvement and operational excellence throughout the organization.
+ Ensure all improvement initiatives align with the company's Safety, Quality, Delivery, and Cost (SQDC) priorities, with safety being the most critical.
+ Lead change initiatives, ensuring smooth adoption of new & existing standard work within teams
+ Provide technical solutions for chemical process issues. This can include MOC's, & small project development.
+ Serve as subject matter expert for PHA's, MOC's, & Root Cause Analysis.
+ Facilitate Problem Solving Reports & Root Cause Analysis for safety or production related issues.
**Required Qualifications**
+ Bachelor's Degree in Engineering from accredited college or university (or a high school diploma / GED with a minimum of 4 years of chemical manufacturing experience)
+ 3 years of experience in optimizing chemical manufacturing operations
**Desired Characteristics**
+ Experience with driving standard work across a broad team.
+ Proven track record of leading successful continuous improvement projects.
+ Able to apply fundamental knowledge appropriately to solve process problems.
+ Data driven- relies heavily on data to drive decisions.
+ Strong written and oral communication skills. Able to explain complex issues to a wide array of audiences.
+ Ability to prioritize "the many" problems/ opportunities down to the "vital few" and generate action plans to address.
+ Humble: respectful, receptive, agile, eager to learn.
+ Transparent: shares critical information, speaks with candor, contributes constructively.
+ Focused: quick learner, strategically prioritizes work, committed.
+ Leadership abilities: strong communicator, decision-maker, collaborative with cross-functional teams.
+ Chemical aptitude and good understanding of hazards as it relates industrial chemicals.
+ At least 3 years of experience in PSM covered chemical manufacturing.
+ Good understanding of failure analysis/ problem solving tools (5-Why, RCA, DMAIC, FMEA).
GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. ?
GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.
_This role requires access to U.S. export-controlled information. Therefore, for applicants who are not asylees, refugees, lawful permanent residents or U.S. Citizens (i.e., not a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3), otherwise known as a U.S. Person), final offers will be contingent on the ability to obtain authorization for access to U.S. export-controlled information from the U.S. Government._
**Additional Information**
GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer ( . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
**Relocation Assistance Provided:** Yes
GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

**Position Overview**
The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be24/7 operational and the role may require to be flexible with working hours and shift rotation.
**Job Description**
**What You'll Do**
_During Project Phase:_
+ Supports operational readiness initiatives as well as site commissioning and qualification efforts
_In Operations:_
+ Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
+ Coordinates Batch Planning including process template creation, import and management of preventative maintenance (PMs)
+ Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)
+ Coordinates of non-batch activities including Changeover, PMs and column packing
+ Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
+ Supports tech transfer within manufacturing domain
+ Ensures compliance and safety procedures are followed in manufacturing environment
+ Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
+ Identifies and/or drives improvement projects in drug substance manufacturing
+ Assists and supports inspections and audits. Provides support to ensuring compliance within the manufacturing environment
+ Other duties as assigned
**Basic Requirements**
+ High School Diploma/GED and 10 years of related experience **OR**
+ Associate's degree, preferably in life sciences or engineering with 8 years of direct experience **OR**
+ Bachelor's degree preferably in life sciences or engineering with 6 years of direct experience **OR**
+ Equivalent Military experience/training
**Preferred Requirements**
+ Strong cGMP manufacturing operations experience
+ Understanding of operations sequence and cadence of activities
+ Prior experience in updating and creating manufacturing documents per schedule
+ BioWorks or BTEC Capstone cGMP coursework preferred
**Physical Requirements & Working Environment**
+ Ability to discern audible cues
+ Ability to ascend or descend ladders, scaffolding, ramps, etc.
+ Ability to stand for prolonged periods of time
+ Ability to sit for prolonged periods of time
+ Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
+ Ability to conduct work that includes moving objects up to 10 pounds
+ Will work in heights greater than 4 feet
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _2 weeks ago_ _(7/18/2025 2:34 PM)_
**_Requisition ID_** _2025-35162_
**_Category_** _Manufacturing_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

We are currently looking to fill an External Manufacturing Specialist position. The External Manufacturing Specialist oversees all aspects of contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.
In this role, a typical day might include the following:
- Serving as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
- Coordinating external manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise.
- Liaison between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
- Leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
- Supporting all investigations which concern external manufacturing and associated shipping operations.
- Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
- Performing reviews of pre-production master batch records and executed batch records.
- Traveling up to 25% (domestic and international), as required.
This role might be for you if:
- Knowledge of external manufacturing from formulation through the final package.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
- Strong interpersonal, written and oral communication skills.
- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
- Gains understanding from provided instructions and works towards goals with minimal supervision.
- Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
- Shows resiliency and flexibility in the face of challenges and adversarial situations.
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
- Experience in collaborating with CMOs/CROs preferred.
To be considered for the Specialist you must have a BS/BA in scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$66,400.00 - $108,400.00