Validation Engineer
Amgen
August 24, 2026
On-site
West Greenwich, RI
Operations
Validation Engineer
Responsibilities:
- Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities (validation planning, protocol development/execution, performance qualification, equipment release, lifecycle documentation).
- Plan, coordinate, and execute equipment/system qualification across technologies (CIP, SIP, autoclave systems, airflow visualization studies, benchtop equipment, supporting utilities) using risk- and science-based approaches.
- Serve as validation technical expert during project planning, equipment implementation, design reviews, and change control; interpret engineering/automation/process/equipment documentation to determine validation requirements and testing approaches; develop/author validation plans.
- Generate, review, and approve validation documentation and provide validation impact assessments for changes/projects/equipment modifications.
- Investigate technical issues and develop solutions to moderate-complexity validation challenges.
- Execute/support cleaning validation and continued cleaning verification.
- Maintain site cleaning acceptance criteria, including calculating MAC (maximum allowable carryover) and providing scientific justification.
- Drive continuous improvement of validation programs/procedures and deliver training to manufacturing staff.
Basic Qualifications:
- High school diploma/GED + 8 years manufacturing/operations OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s degree.
Preferred Qualifications:
- GMP pharma/biotech manufacturing experience (upstream and/or downstream).
- Hands-on validation experience (equipment qualification, sterilization/steaming, cleaning validation, performance studies).
- Technical understanding of unit operations/equipment/processes; ability to interpret engineering/automation documentation.
- Strong GMP and CFR/regulatory understanding; analytical/experimental design; technical writing; communication and cross-functional coordination; independent work and priority management.
Benefits:
- Comprehensive employee benefits package (including retirement/savings plan, medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus (or sales incentive for field reps), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com; no application deadline—applications continue until sufficient applicants are received or a candidate is selected.
Responsibilities:
- Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities (validation planning, protocol development/execution, performance qualification, equipment release, lifecycle documentation).
- Plan, coordinate, and execute equipment/system qualification across technologies (CIP, SIP, autoclave systems, airflow visualization studies, benchtop equipment, supporting utilities) using risk- and science-based approaches.
- Serve as validation technical expert during project planning, equipment implementation, design reviews, and change control; interpret engineering/automation/process/equipment documentation to determine validation requirements and testing approaches; develop/author validation plans.
- Generate, review, and approve validation documentation and provide validation impact assessments for changes/projects/equipment modifications.
- Investigate technical issues and develop solutions to moderate-complexity validation challenges.
- Execute/support cleaning validation and continued cleaning verification.
- Maintain site cleaning acceptance criteria, including calculating MAC (maximum allowable carryover) and providing scientific justification.
- Drive continuous improvement of validation programs/procedures and deliver training to manufacturing staff.
Basic Qualifications:
- High school diploma/GED + 8 years manufacturing/operations OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s degree.
Preferred Qualifications:
- GMP pharma/biotech manufacturing experience (upstream and/or downstream).
- Hands-on validation experience (equipment qualification, sterilization/steaming, cleaning validation, performance studies).
- Technical understanding of unit operations/equipment/processes; ability to interpret engineering/automation documentation.
- Strong GMP and CFR/regulatory understanding; analytical/experimental design; technical writing; communication and cross-functional coordination; independent work and priority management.
Benefits:
- Comprehensive employee benefits package (including retirement/savings plan, medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus (or sales incentive for field reps), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com; no application deadline—applications continue until sufficient applicants are received or a candidate is selected.