6442 - Senior CQV Engineer / Senior Validation Engineer

Job Overview 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 requires 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 Manage discrepancies and punch/deviation handoff Own assigned process equipment document sets from planning through execution, including QP/DQ/QRA/DI/ERES/configuration/traceability, commissioning documents, IOQ/PQ, blue tag, and close‑out 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 10+ years CQV experience 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 Ability to author/review protocols and execute in the field—including walkdowns, receipt verification, commissioning checks, IOQ testing, discrepancy documentation, and final report close‑out Experience with bioreactors, chromatography systems, TFF systems, centrifuges, mixing systems, and single‑use technologies ValGenesis execution/routing experience preferred; candidate must be comfortable with electronic protocol evidence expectations Must work closely with engineering, vendors, construction turnover, operations/MS&T, quality, automation/IT, and the senior validation SME Location & Schedule On‑site, full‑time in Devens, MA. Salary National (US) Range: $70,491 – $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 Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account Paid Time Off (Rollover Option) and Holidays As‑needed Sick Time Tuition Reimbursement Team Social Activities Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement EEO Statement Verista is an equal opportunity employer. #J-18808-Ljbffr Verista, Inc.