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 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.
Senior Validation Engineer 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
Job 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.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.National (US) Range
$70,491-$113,521 USD
BenefitsWhy Choose Verista?
- 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
