6442 - Senior CQV Engineer / Senior Validation Engineer

About the Role

We are seeking a Senior CQV Engineer to 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.

Responsibilities

• 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

Requirements

• 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

Pay

National (US) Range: $70,491 USD - $113,521 USD

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement