6442 - Senior CQV Engineer / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →Own process equipment document set and execution readiness
• →Lead system walkdowns
• →Author/review QP/IOC/CSR/IOQ/QSR/TM
• →Coordinate vendor protocols
• →Manage discrepancies and punch/deviation handoff
• →Own assigned process equipment document sets from planning through execution and QSR: QP/DQ/QRA/DI/ERES/configuration/traceability as applicable, commissioning documents, IOQ/PQ, blue tag, and closeout
• →Coordinate with equipment suppliers for startup, vendor documentation, SAT execution, turnover documentation, and technical issue resolution
• →Manage turnover package review, receipt verification, construction/commissioning evidence, punch items, test exceptions, and deviation handoff
• →Feed accurate system status, blockers, and recovery needs into PM/document control trackers

• Bachelor’s Degree or equivalent required
• 10+ years process equipment CQV in biologics, cell therapy, gene therapy, viral vector, vaccine, or sterile manufacturing environments
• Hands-on familiarity with single-use bioreactors, wave bioreactors, mixers, ATF, depth filtration, chromatography, UF/DF/TFF, transfer panels, TCUs, process pumps/skids, and filter integrity testing
• Experience reviewing vendor FAT/SAT packages and turning them into leveraged qualification evidence with clear punch-item and deviation handling
• Can author/review protocols and execute in the field, including walkdowns, receipt verification, commissioning checks, IOQ testing, discrepancy documentation, and final report closeout
• Experience with Bioreactors, Chromatography systems, TFF systems, Centrifuges, Mixing systems, Single-use technologies
• ValGenesis execution/routing experience is preferred; candidate must be comfortable with electronic protocol evidence expectations.
• Must work closely with engineering, vendors, construction turnover, operations/MS&T, quality, automation/IT as needed, and the senior validation SME

This role requires the ability to be on-site, full-time in Devens, MA.