Specialist Manufacturing: Manufacturing Execution System (MES)
Amgen
July 02, 2026
On-site
Holly Springs, NC
IT
What You Will Do
- Communicate and interface between GMP manufacturing teams at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development groups.
- Ensure Electronic Batch Records accurately document the manufacturing process and drive batch record optimization between the manufacturing floor and the global MES team.
- Coordinate with the Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support new products/technologies.
- Serve as a subject matter expert leading and/or participating in projects to ensure Koerber PAS|X electronic batch records capture all required process data for unit operations.
- Support Manufacturing troubleshooting, problem solving, and RCAs; support CAPA development.
- Own Generic Master Batch Record (GMBR) optimizations; act as primary liaison between site MES and global MES team; respond to regulatory questions and/or audit findings.
- Champion Lean Transformation and OE initiatives; facilitate continuous improvement and track plant progress.
- Support batch record standardization for network-wide use of generic batch records.
Basic Qualifications
- Doctorate degree OR
- Master’s in chemistry, biology, or engineering + 3 years biotechnology operations experience OR
- Bachelor’s degree + 5 years biotechnology operations experience OR
- Associate’s degree + 10 years biotechnology operations experience OR
- High school diploma/GED + 12 years biotechnology operations experience
Preferred Qualifications
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
- Cross-functional project management, meeting facilitation, and technical writing
- Experience in GMP manufacturing operations
- Technical knowledge of drug substance processing (inoculation, bioreactors, harvest, chromatography, filtration, buffer preparation)
- Extensive Koerber PAS|X (or comparable) electronic batch record design experience; understanding of editing/validation
- Ability to communicate complex technical information (presentation and writing)
- Ability to coach/mentor and/or cross-train colleagues
Benefits (Total Rewards Plan)
- Comprehensive employee benefits (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts)
- Discretionary annual bonus (or sales incentive plan for field sales)
- Stock-based long-term incentives
- Award-winning time-off and bi-annual company-wide shutdowns
- Flexible work models (remote where possible)
Application Instructions
- Apply via careers.amgen.com
- Communicate and interface between GMP manufacturing teams at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development groups.
- Ensure Electronic Batch Records accurately document the manufacturing process and drive batch record optimization between the manufacturing floor and the global MES team.
- Coordinate with the Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support new products/technologies.
- Serve as a subject matter expert leading and/or participating in projects to ensure Koerber PAS|X electronic batch records capture all required process data for unit operations.
- Support Manufacturing troubleshooting, problem solving, and RCAs; support CAPA development.
- Own Generic Master Batch Record (GMBR) optimizations; act as primary liaison between site MES and global MES team; respond to regulatory questions and/or audit findings.
- Champion Lean Transformation and OE initiatives; facilitate continuous improvement and track plant progress.
- Support batch record standardization for network-wide use of generic batch records.
Basic Qualifications
- Doctorate degree OR
- Master’s in chemistry, biology, or engineering + 3 years biotechnology operations experience OR
- Bachelor’s degree + 5 years biotechnology operations experience OR
- Associate’s degree + 10 years biotechnology operations experience OR
- High school diploma/GED + 12 years biotechnology operations experience
Preferred Qualifications
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
- Cross-functional project management, meeting facilitation, and technical writing
- Experience in GMP manufacturing operations
- Technical knowledge of drug substance processing (inoculation, bioreactors, harvest, chromatography, filtration, buffer preparation)
- Extensive Koerber PAS|X (or comparable) electronic batch record design experience; understanding of editing/validation
- Ability to communicate complex technical information (presentation and writing)
- Ability to coach/mentor and/or cross-train colleagues
Benefits (Total Rewards Plan)
- Comprehensive employee benefits (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts)
- Discretionary annual bonus (or sales incentive plan for field sales)
- Stock-based long-term incentives
- Award-winning time-off and bi-annual company-wide shutdowns
- Flexible work models (remote where possible)
Application Instructions
- Apply via careers.amgen.com