Process Engineer II – GMP Equipment Lifecycle

Lumen Bioscience; Seattle (WA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health, Dental, Vision premiums fully–

401k match up to 4%

Generous PTO and holidays

Paid wellness program

Onsite parking or transit subsidies

Parental leave

Life and disability insurance

Job summary

Lumen Bioscience is seeking a Process Engineer II to steward GMP equipment lifecycle from onboarding to qualification and validation, ensuring compliant manufacturing.

You will collaborate with Engineering, Process Development, Quality, and Operations to optimize scale-up, lead troubleshooting, preventive maintenance, and change controls while maintaining a strong quality mindset in a fast-paced biomanufacturing setting.

Qualifications

• Bachelor's degree in an engineering discipline is required.
• 5+ years of relevant process or equipment engineering experience in cGMP environments.
• Experience supporting equipment qualification/validation (IQ/OQ/PQ) and preventive maintenance programs.

Responsibilities

• Own the GMP equipment lifecycle from onboarding, commissioning, qualification and validation.
• Troubleshoot equipment/process failures and lead root cause investigations and CAPAs.
• Design, run and analyze equipment/process focused experiments to improve yield and robustness.
• Prepare and update SOPs, instructions, cleaning and changeover procedures, and batch records.

Skills

Mechanical aptitude

Troubleshooting

Root cause analysis

Project management

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Job description

Lumen Bioscience is seeking a Process Engineer II to steward GMP equipment lifecycle from onboarding to qualification and validation, ensuring compliant manufacturing.

You will collaborate with Engineering, Process Development, Quality, and Operations to optimize scale-up, lead troubleshooting, preventive maintenance, and change controls while maintaining a strong quality mindset in a fast-paced biomanufacturing setting.