GMP Equipment Lifecycle Engineer II

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

Benefits offered by this job

Health, Dental, Vision fully covered

401k match up to 4%

Generous PTO and paid holidays

Wellness program

Job summary

Lumen Bioscience, Inc. is seeking a Process Engineer II to manage the lifecycle of GMP manufacturing equipment, from onboarding and commissioning through qualification, validation and decommissioning.

You will partner with Engineering and Process Development to optimize processes on production-scale equipment. The role requires 5+ years of related experience, strong hands-on troubleshooting, and experience with IQ/OQ/PQ.

Qualifications

• Bachelor’s degree in an engineering discipline is required.
• 5+ years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device environment.
• Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.
• Basic knowledge of cGMP biomanufacturing processes and proficiency with MS Office.

Responsibilities

• Owns the lifecycle of manufacturing equipment from onboarding to decommissioning.
• Troubleshoots equipment/process failures and leads root cause investigations and CAPA.
• Designs and analyzes equipment/process experiments including scale-up/scale-down studies.
• Develops and updates operating procedures, work instructions, and change controls.
• Supports deviations, audits, and regulatory inspections as SME for equipment.

Skills

Mechanical aptitude

Troubleshooting

Equipment qualification

IQ/OQ/PQ

MS Office

Education

Bachelor's degree in engineering

Tools

MS Office

Job description

Lumen Bioscience, Inc. is seeking a Process Engineer II to manage the lifecycle of GMP manufacturing equipment, from onboarding and commissioning through qualification, validation and decommissioning.

You will partner with Engineering and Process Development to optimize processes on production-scale equipment. The role requires 5+ years of related experience, strong hands-on troubleshooting, and experience with IQ/OQ/PQ.