Manufacturing Associate 3, Visual Inspection (Second Shift 3pm to 11:30pm) FUJIFILM Biotechnologies USA IncManufacturing Associate 3, Visual Inspection (Second Shift 3pm to 11:30pm)Holly Springs, NCAll 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. Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection-while helping stand up and optimize a state-of-the-art DP facility.
Manufacturing Associate 4 (Downstream) Day Shift (2 2 3) FUJIFILM Biotechnologies USA IncManufacturing Associate 4 (Downstream) Day Shift (2 2 3)Holly Springs, NCIn this senior role, you will support both project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility-helping ensure safe, consistent, and efficient production of drug substance. All resumes submitted by search firms/employment agencies to any employee via email, the internet, or in any form and/or method will be deemed the sole property of the company, unless such search firms/employment agencies were engaged for this requisition and a valid agreement is in place.
Principal Product Owner, Manufacturing Execution FUJIFILM Biotechnologies USA IncPrincipal Product Owner, Manufacturing ExecutionNCLead Agile ceremonies for multiple scrum teams; define the Definition of Done (functional fit, Part 11/Annex 11, security, performance, data integrity); orchestrate UAT, validation documentation, release cutovers, and hypercare; ensure audit readiness and support inspections. You'll orchestrate Agile delivery with internal and vendor teams, harmonize MES platforms (Syncade and PAS‑X) with DeltaV integration (ISA‑88/95), and ensure compliant, right‑first‑time execution that measurably improves yield, lead time, and productivity.
NewEntry Level: Manufacturing Associate 1 and 2 (Day/Night Shift) FUJIFILM Biotechnologies USA IncEntry Level: Manufacturing Associate 1 and 2 (Day/Night Shift)Holly Springs, NCAll 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. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
NewMid Level: Manufacturing Associate 3 (Day/Night Shift) FUJIFILM Biotechnologies USA IncMid Level: Manufacturing Associate 3 (Day/Night Shift)Holly Springs, NCAll 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. Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Manufacturing Lead Upstream (Nights) FUJIFILM Biotechnologies USA IncManufacturing Lead Upstream (Nights)NCSituated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. 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.
NewManufacturing Associate 3, Filling (Second Shift 3pm to 11:30pm) FUJIFILM Biotechnologies USA IncManufacturing Associate 3, Filling (Second Shift 3pm to 11:30pm)Holly Springs, NCAll 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. Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection-while helping stand up and optimize a state-of-the-art DP facility.
Manufacturing Associate I/II - Night Shift KBI BiopharmaManufacturing Associate I/II - Night ShiftDurham, North Carolina$24–$31.25 / hourThey will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, various other filtration techniques utilizing single use technologies. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT).
Senior Manufacturing Systems Engineer: Automation - DeltaV AmgenSenior Manufacturing Systems Engineer: Automation - DeltaVHolly Springs, North CarolinaDirect knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software. Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday) AmgenManufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday)Holly Springs, North CarolinaDirect knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors,solution prep,single use mixingvessels,chromatography,TFFL/TFFX,viral filtration, viral inactivation,UF/DF,depth filtration, drug substance fill,CIP/SIP, clean utilities,and integrating various OEM automation software. As a member of the Amgen team,you’llhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Senior Manufacturing Systems Engineer - PLC Systems AmgenSenior Manufacturing Systems Engineer - PLC SystemsHolly Springs, North CarolinaWhen completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Senior Manufacturing Systems Engineer – DeltaV AmgenSenior Manufacturing Systems Engineer – DeltaVHolly Springs, North CarolinaWhen completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Manufacturing Execution System (MES) Engineer I/II KBI BiopharmaManufacturing Execution System (MES) Engineer I/IIDurham, North CarolinaGeneration and revision of system lifecycle documentation associated with electronic manufacturing records and logbooks such as Functional/Design/Configuration Specifications, process and data flow charts, supporting risk assessments, and supporting equipment and facility procedures for specific manufacturing process units, as needed. · Generation and revision of electronic manufacturing records and electronic logbooks within the MES platform, including impact/coordination for associated interfaces and databases, as well as support for testing and qualification activities, as needed.
Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness AmgenSpecialist Manufacturing New Product Introduction (NPI):Downstream ReadinessHolly Springs, North CarolinaIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsibilities: New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness AmgenSpecialist Manufacturing New Product Introduction (NPI): Upstream ReadinessHolly Springs, North CarolinaIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsibilities: New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
Associate Manufacturing – Downstream - Nights (Multiple Positions) AmgenAssociate Manufacturing – Downstream - Nights (Multiple Positions)Holly Springs, North CarolinaAmgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Manager Manufacturing Systems Engineering - Automation (Multiple Positions) AmgenSenior Manager Manufacturing Systems Engineering - Automation (Multiple Positions)Holly Springs, North CarolinaAmgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsible for ensuring that the automation team actively participates in daily/weekly Work Center Team (WCT) meetings – Manufacturing area & plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.
Manufacturing Systems Engineer: Automation - Delta V AmgenManufacturing Systems Engineer: Automation - Delta VHolly Springs, North CarolinaDirect knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Senior Manufacturing Systems Engineer: Automation PLC AmgenSenior Manufacturing Systems Engineer: Automation PLCHolly Springs, North CarolinaWhen completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and integrating various OEM automation software.
Senior Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday) AmgenSenior Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday)Holly Springs, North CarolinaWhen completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software. .