Process Analytical Engineer
Amgen
June 26, 2026
On-site
Holly Springs, NC
Operations
Process Analytical Engineer
What You Will Do
- Plan, execute, and document qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control lab facilities (ANC).
- Perform hands-on troubleshooting and root cause analysis for analytical/lab systems; coordinate vendor support and repairs.
- Execute and track calibration, maintenance, and requalification activities via CMMS (Maximo).
- Author, own, and approve Validation Life Cycle documents for computer-related systems; own Data Integrity testing and business administration for lab computer-related systems.
- Support commissioning/qualification/validation and system lifecycle documentation for compliance and readiness.
- Partner with manufacturing teams to resolve issues, improve reliability, and minimize downtime.
Key responsibilities
- System ownership, reliability, and safe operations (EHS and design requirements compliance).
- System Owner/Business Administrator for analytical equipment.
- Lead/work on design, development, and selection of new systems/instruments; develop equipment specifications for procurement.
- Maintain knowledge of regulatory requirements for equipment qualification and calibration.
- Resolve protocol discrepancies; alert QC management of calibration/qualification failures and conduct impact assessments.
- Lead calibration/maintenance programs, spare parts planning, scheduling, and maintenance coordination.
- Subject matter expert on instrument validation regulations/procedures.
- Evaluate suppliers/technologies; write/update operating procedures and manuals; design and conduct training.
- Manage change controls; provide management updates; review instrument validation within the validation life cycle.
- Contribute to Data Integrity assessments; support lab validation and Data Integrity during audits.
- Cross-functional support and continuous improvement; troubleshooting/technical RCA and CAPA (may require nights/weekends/holidays); support new product/tech introductions; support 24/7 operations.
Basic Qualifications
- Master’s degree
OR Bachelor’s degree + 2 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
OR Associate’s degree + 6 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
OR High school diploma/GED + 8 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
Preferred Qualifications
- Bachelor’s degree in engineering/related technical field
- cGMP lab experience with analytical instrument validation
- Biopharmaceutical testing methodology/instrumentation knowledge
- Regulatory knowledge for cGMP equipment validation and electronic record integrity
- Experience managing equipment qualification/maintenance programs
- On-call coverage nights/weekends (rotating)
- Strong written/verbal skills; ability to work with minimal direction
- Interpersonal/facilitation skills in collaborative teams; analytical problem-solving
- Work schedule flexibility for 24/7 operations; domestic/international travel
Application instructions
- Apply now via careers.amgen.com
What You Will Do
- Plan, execute, and document qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control lab facilities (ANC).
- Perform hands-on troubleshooting and root cause analysis for analytical/lab systems; coordinate vendor support and repairs.
- Execute and track calibration, maintenance, and requalification activities via CMMS (Maximo).
- Author, own, and approve Validation Life Cycle documents for computer-related systems; own Data Integrity testing and business administration for lab computer-related systems.
- Support commissioning/qualification/validation and system lifecycle documentation for compliance and readiness.
- Partner with manufacturing teams to resolve issues, improve reliability, and minimize downtime.
Key responsibilities
- System ownership, reliability, and safe operations (EHS and design requirements compliance).
- System Owner/Business Administrator for analytical equipment.
- Lead/work on design, development, and selection of new systems/instruments; develop equipment specifications for procurement.
- Maintain knowledge of regulatory requirements for equipment qualification and calibration.
- Resolve protocol discrepancies; alert QC management of calibration/qualification failures and conduct impact assessments.
- Lead calibration/maintenance programs, spare parts planning, scheduling, and maintenance coordination.
- Subject matter expert on instrument validation regulations/procedures.
- Evaluate suppliers/technologies; write/update operating procedures and manuals; design and conduct training.
- Manage change controls; provide management updates; review instrument validation within the validation life cycle.
- Contribute to Data Integrity assessments; support lab validation and Data Integrity during audits.
- Cross-functional support and continuous improvement; troubleshooting/technical RCA and CAPA (may require nights/weekends/holidays); support new product/tech introductions; support 24/7 operations.
Basic Qualifications
- Master’s degree
OR Bachelor’s degree + 2 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
OR Associate’s degree + 6 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
OR High school diploma/GED + 8 years cGMP lab, analytical instrument validation, and/or Process Engineer experience
Preferred Qualifications
- Bachelor’s degree in engineering/related technical field
- cGMP lab experience with analytical instrument validation
- Biopharmaceutical testing methodology/instrumentation knowledge
- Regulatory knowledge for cGMP equipment validation and electronic record integrity
- Experience managing equipment qualification/maintenance programs
- On-call coverage nights/weekends (rotating)
- Strong written/verbal skills; ability to work with minimal direction
- Interpersonal/facilitation skills in collaborative teams; analytical problem-solving
- Work schedule flexibility for 24/7 operations; domestic/international travel
Application instructions
- Apply now via careers.amgen.com