Validation Engineer
Amgen · West Greenwich, RI
The apply link worked recently (not employer-confirmed).
Role summary
This role supports equipment and system validation activities within a biotech manufacturing facility. The engineer will develop validation strategies, coordinate qualification testing across multiple technologies, and serve as a technical expert for equipment implementation and change management. Responsibilities include protocol development, cleaning validation, documentation review, and continuous improvement of validation programs.
What they're looking for
- Bachelor's degree with 2+ years manufacturing and operations experience
- GMP pharmaceutical or biotechnology manufacturing environment exposure
- Hands-on validation experience with manufacturing equipment and facility systems
- Technical understanding of pharmaceutical/biotechnology unit operations
- Ability to interpret engineering and automation documentation
- Strong understanding of GMP requirements and CFR/regulatory expectations
- Analytical and experimental design skills with technical writing proficiency
What you'll be doing
- Execute validation activities for manufacturing equipment, support equipment, utilities, and lifecycle documentation
- Plan and coordinate equipment and system qualification across CIP, SIP, autoclave, and utility systems
- Serve as validation technical expert during project planning, design reviews, and change control
- Generate, review, and approve validation documentation and impact assessments
- Execute cleaning validation and develop solutions for validation challenges
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.