Lumen Bioscience
Process Engineer II - GMP Equipment Lifecycle
- Confirmed live in the last 24 hours
- $80k–$110k
- Mid level
- On-site · Seattle, WA
- 5+ yrs exp
- Added 1 month ago
About this role
Lumen Bioscience is seeking a Process Engineer II to manage the lifecycle of GMP manufacturing equipment within their spirulina-based biomanufacturing platform. You will own equipment onboarding, qualification, and validation, while also troubleshooting issues, improving processes, and ensuring compliance with cGMP regulations. This position offers a supportive environment and the opportunity to contribute to advancements in biotechnology.
What you'll do
- Own equipment onboarding, commissioning, qualification, and validation.
- Develop and improve preventative maintenance programs and cleaning procedures.
- Troubleshoot equipment failures and lead root cause investigations (CAPA).
- Design and analyze equipment and process experiments.
- Author and revise equipment operating procedures and technical documentation.
- Support deviations, change controls, audits, and regulatory inspections.
What they're looking for
- Equipment Qualification & Validation (IQ/OQ/PQ)
- Preventative Maintenance Programs
- cGMP (21 CFR Part 111 / 117 / 210 / 211)
- Microsoft Office Suite
- Technical Documentation
- Process Optimization
- Scale-up/Scale-down Studies
Benefits
- Health, Dental, and Vision (fully covered)
- 401k match (up to 4%)
- Industry-leading PTO
- Paid refresh days
- Wellness program
- Free onsite parking/transportation subsidies
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Lumen Bioscience
Likely interview questions
- Describe your experience with equipment qualification and validation (IQ/OQ/PQ).
- Can you walk me through your approach to troubleshooting a recurring equipment failure?