Process Engineer II - GMP Equipment Lifecycle

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.

• GMP Equipment Lifecycle: Owning the onboarding, commissioning, qualification and validation of new GMP process equipment.
• Preventative maintenance management: Development and improvement of work instructions. Establishing cleaning and sanitization procedures.
• Manufacturing Process: Partner closely with Engineering and Process Development teams to characterize and optimize manufacturing processes as it is executed on production-scale drug substance and drug product equipment.
• Team Collaboration: Work closely with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training to enhance operational efficiency and compliance.

• →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.

• Educational Background: Bachelor’s degree in an engineering discipline (e.g. Mechanical, Chemical, Biomedical, Industrial) required.
• Professional Experience: 5+years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment.
• Technical Knowledge: Strong mechanical aptitude and hands-on equipment troubleshooting experience. Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.
• Technical Skills: Basic knowledge of food, dietary supplement, biotechnology and biomanufacturing processes per cGMP (21 CFR Part 111 / 117 / 210 / 211). Proficient in Microsoft Office Suite.
• Personal Attributes: 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.