Process Engineer II - GMP Equipment Lifecycle

Lumen Bioscience • Seattle, WA

44d • $80,000 - $110,000 • Onsite

About The Position

Lumen Bioscience is seeking a qualified Process Engineer who will be responsible for supporting Lumen's spirulina-based biomanufacturing platform through the lifecycle management of GMP manufacturing equipment. This role involves owning the onboarding, commissioning, qualification, and validation of new GMP process equipment, as well as developing and improving preventative maintenance programs, work instructions, and cleaning/sanitization procedures. The Process Engineer will also partner closely with Engineering and Process Development teams to characterize and optimize manufacturing processes and collaborate with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training for enhanced operational efficiency and compliance.

Requirements

• Bachelor’s degree in an engineering discipline (e.g. Mechanical, Chemical, Biomedical, Industrial) required.
• 5+ years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong mechanical aptitude and hands-on equipment troubleshooting experience.
• Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.
• Basic knowledge of food, dietary supplement, biotechnology and biomanufacturing processes per cGMP (21 CFR Part 111 / 117 / 210 / 211).
• Proficient in Microsoft Office Suite.
• Detail-oriented, highly organized, proactive, with the ability to manage multiple tasks simultaneously in a fast-paced environment.
• Strong interpersonal skills and commitment to quality and ethical standards.
• Ability to sit, stand and walk for extended periods (2+ hours) in a manufacturing or production environment.
• Occasionally lift or carry items up to 20 kg.
• Ability to gown and work in controlled and classified (cleanroom) environments and around production equipment.

Responsibilities

• Serve as the technical owner for manufacturing equipment through its lifecycle: coordinating pre-purchase requirements, safety assessments, training, startup change control, periodic review and eventual decommissioning.
• Troubleshoot equipment and process failures and lead root cause investigations, corrective and preventative actions (CAPA), and reliability improvements to minimize downtime and improve contamination control.
• Design, execute and analyze equipment and process-focused experiments – including optimization, scale-up and scale-down studies – to improve yield, throughput, robustness and product quality.
• Author, revise and continuously improve equipment operating procedures, work instructions, cleaning, set-up and changeover instructions, technical documentation including engineering studies and impact assessments, associated risk assessments and batch records steps to ensure safe, reproducible, compliant processes.
• Support deviations, change controls, internal and external audits and regulatory inspections as the equipment subject matter expert.

Benefits

• Health, Dental, and Vision premiums fully covered by Lumen.
• 401k match up to 4%.
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure.
• Monthly wellness program to support your health and well-being.
• Free onsite parking or public transportation subsidies.
• Comprehensive parental leave policies.
• Life insurance, short & long-term disability, and access to employee assistance programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level