Biotech Manufacturing Engineer I
Amgen
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Job summary
Amgen Thousand Oaks is seeking an Engineer I to support manufacturing activities for cGMP equipment and facilities. You will collaborate with Automation, Maintenance, Project Management, and QA to develop and maintain equipment reliability, quality, and safety while driving continuous improvement.
The role requires working knowledge of regulated environments, with a focus on validation, documentation, and risk-based verification.
Qualifications
- Master’s degree or equivalent with multiple pathways listed for qualification
- Experience in regulated manufacturing environments and FDA/OSHA/EPA familiarity
- Strong knowledge of cGMP procedures and engineering practices in biotech/pharma
- Experience implementing risk-based verification on major GMP equipment/projects
- Experience with SOP development and training delivery
- Excellent communication and collaboration skills
Responsibilities
- Support manufacturing activities with cGMP equipment and facilities
- Lead/participate in project planning, execution, and closeout
- Ensure validation protocols are executed and documented
- Drive continuous improvement and cost/safety/quality enhancements
- Mentor project teams and engineers in risk-based approaches
- Interface with Engineering, Automation, Maintenance, Instrumentation, and QA during projects
Skills
Education
Tools
Job description
Amgen Thousand Oaks is seeking an Engineer I to support manufacturing activities for cGMP equipment and facilities. You will collaborate with Automation, Maintenance, Project Management, and QA to develop and maintain equipment reliability, quality, and safety while driving continuous improvement.
The role requires working knowledge of regulated environments, with a focus on validation, documentation, and risk-based verification.
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