CQV System Lead - Viral Vector Process Equipment

Lead C&Q documentation, vendor leveraging, walkdowns, commissioning readiness, and qualification execution for viral vector drug substance process equipment and related single-use process systems. This role needs a field-capable biologics process equipment validation lead who can own systems through turnover, SAT, commissioning, IOQ, evidence review, discrepancy resolution, and final reports.

Project scope to screen against:

• Relevant systems include N-2 Wave Bioreactor, N-1 Wave Bioreactors, N Production 500L Bioreactor, ATF 10, harvest pump skid, single-use chromatography skid, single-use UF/DF skid, jacketed single-use mixers, temperature control units, filter integrity testers, tubing welders/sealers, cell culture support equipment, and related utility panels.
• Several systems are equipment with computerized systems and require ERES/data integrity/configuration thinking in addition to mechanical/process qualification.
• Process equipment deliverables include system requirements, SLIA/SCA where applicable, design review, DQ, QRA, data integrity risk assessment, configuration specification, traceability matrix, FAT/SAT where applicable, commissioning protocol/report, IOQ, QSR, green tag, blue tag, and PQ where applicable.
• Some systems are new, modified, existing, or relocated, so the candidate must be able to assess existing evidence and determine the practical path to commissioning/qualification readiness.
• Lead CQV activities for upstream and downstream viral vector processing equipment.
• Coordinate commissioning with Engineering, Vendors, and Construction teams.
• Execute and review commissioning, IQ, OQ, and PQ protocols.
• Manage punch lists, deviations, change controls, and CAPAs.
• Coordinate equipment startup and operational readiness.
• Ensure documentation complies with project and regulatory standards.
• Provide daily coordination with Manufacturing and Quality, * 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.

Project deliverables / ownership:

• 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.

• 10+ years process equipment CQV in biologics/cell therapy/gene therapy
• Bioreactors
• Chromatography systems
• TFF systems
• Centrifuges
• Mixing systems
• Single-use technologies
• Strong GMP and validation knowledge.
• single-use systems
• vendor FAT/SAT leveraging
• protocol author/execution
• field troubleshooting., * 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., * 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.
• Hybrid role with onsite presence during FAT/SAT, walkdowns, commissioning, and IOQ execution windows in Devens, MA.