Process Engineer II - GMP Equipment Lifecycle

<p><strong>Process Engineer II - GMP Equipment Lifecycle</strong></p> <p>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.</p> <p><strong>Role Description:</strong></p> <ul> <li><strong>GMP Equipment Lifecycle:</strong>&nbsp;Owning the onboarding, commissioning, qualification and validation of new GMP process equipment.</li> <li><strong>Preventative maintenance management: </strong>Development and improvement of work instructions. Establishing cleaning and sanitization procedures.</li> <li><strong>Manufacturing Process:</strong>&nbsp;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.</li> <li><strong>Team Collaboration:</strong>&nbsp;Work closely with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training to enhance operational efficiency and compliance.</li> </ul> <p><strong>Essential Duties and Responsibilities:</strong></p> <ul> <li>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.</li> <li>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.</li> <li>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.</li> <li>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.</li> <li>Support deviations, change controls, internal and external audits and regulatory inspections as the equipment subject matter expert.</li> </ul> <p><strong>Qualifications &amp; Requirements:</strong></p> <ul> <li><strong>Educational Background:</strong>&nbsp;Bachelor’s degree in an engineering discipline (e.g. Mechanical, Chemical, Biomedical, Industrial) required.</li> <li><strong>Professional Experience:</strong>&nbsp;5+years of relevant process or equ