Process Analytical Engineer
Amgen
August 15, 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.
- Perform hands-on troubleshooting and root cause analysis for analytical/lab systems; coordinate vendor support and repairs.
- Execute and track calibration, maintenance, and requalification via CMMS (Maximo).
- Author, own, and approve Validation Life Cycle documents for computer-related systems, including Data Integrity testing and business administration of lab computer-related systems.
Key Responsibilities
- Support commissioning, qualification, validation, and lifecycle documentation for compliance and readiness.
- Partner with manufacturing teams to improve reliability and minimize downtime.
- Serve as System Owner and Business Administrator for analytical equipment.
- Lead/support design, development, and selection of new systems/instruments; develop equipment specifications for procurement.
- Maintain knowledge of regulatory requirements for equipment qualification/calibration.
- Lead calibration/maintenance programs; ensure spare parts; schedule and coordinate maintenance.
- Support instrument validation SMEs, protocol discrepancy resolution, impact assessments, and change controls.
- Conduct validation/instrument validation reviews; support Data Integrity assessments and audit interactions.
- Provide cross-functional engineering support and continuous improvement (investigations, risk reduction, CAPA, troubleshooting, new technology introductions, predictive/condition-based maintenance).
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/Process Engineer experience; OR
- High school diploma/GED + 8 years cGMP lab/analytical instrument validation/Process Engineer experience.
Preferred Qualifications
- Bachelor’s degree in engineering/related field; cGMP lab experience with analytical instrument validation.
- Knowledge of biopharmaceutical testing methods/instrumentation; cGMP equipment validation and electronic record integrity requirements.
- Experience managing equipment qualification or maintenance programs.
- On-call nights/weekends (rotating), strong written/verbal skills, minimal-direction work ability, facilitation/interpersonal skills, analytical problem-solving.
- Cross-functional collaboration; flexibility for 24/7 operations; domestic/international travel.
Application Instructions
- Apply at 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.
- Perform hands-on troubleshooting and root cause analysis for analytical/lab systems; coordinate vendor support and repairs.
- Execute and track calibration, maintenance, and requalification via CMMS (Maximo).
- Author, own, and approve Validation Life Cycle documents for computer-related systems, including Data Integrity testing and business administration of lab computer-related systems.
Key Responsibilities
- Support commissioning, qualification, validation, and lifecycle documentation for compliance and readiness.
- Partner with manufacturing teams to improve reliability and minimize downtime.
- Serve as System Owner and Business Administrator for analytical equipment.
- Lead/support design, development, and selection of new systems/instruments; develop equipment specifications for procurement.
- Maintain knowledge of regulatory requirements for equipment qualification/calibration.
- Lead calibration/maintenance programs; ensure spare parts; schedule and coordinate maintenance.
- Support instrument validation SMEs, protocol discrepancy resolution, impact assessments, and change controls.
- Conduct validation/instrument validation reviews; support Data Integrity assessments and audit interactions.
- Provide cross-functional engineering support and continuous improvement (investigations, risk reduction, CAPA, troubleshooting, new technology introductions, predictive/condition-based maintenance).
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/Process Engineer experience; OR
- High school diploma/GED + 8 years cGMP lab/analytical instrument validation/Process Engineer experience.
Preferred Qualifications
- Bachelor’s degree in engineering/related field; cGMP lab experience with analytical instrument validation.
- Knowledge of biopharmaceutical testing methods/instrumentation; cGMP equipment validation and electronic record integrity requirements.
- Experience managing equipment qualification or maintenance programs.
- On-call nights/weekends (rotating), strong written/verbal skills, minimal-direction work ability, facilitation/interpersonal skills, analytical problem-solving.
- Cross-functional collaboration; flexibility for 24/7 operations; domestic/international travel.
Application Instructions
- Apply at careers.amgen.com.