Process Engineer II - GMP Equipment Lifecycle

Job description

**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. **Role Description:** - **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. **Essential Duties and 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. **Qualifications & Requirements:** - **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. **Physical Requirements:** - 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. **Salary & Benefits at Lumen Bioscience:** - $80,000 to $110,000 salary range, depending on experience. - 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. At Lumen Bioscience, we foster a workplace that encourages innovation, collaboration, and professional growth. This role offers an opportunity to enhance your compliance expertise while contributing significantly to advancements in biotechnology and global health solutions. **Join us and play a crucial role in ensuring manufacturing compliance and quality excellence.** Compensation Range $80,000—$110,000 USD