Job Overview: We are seeking a CQV Documentation Specialist / Project Engineer to support high-volume CQV documentation, QSR generation, package assembly, traceability, and closeout for a GMP equipment qualification project. This role is critical to ensuring documentation deliverables remain aligned with the project schedule and inspection-ready expectations.
Project Engineer Responsibilities:- Support generation, formatting, routing, tracking, and closeout of CQV deliverables
- Support URS revisions, readiness checklist packages, IOQ/PQ packages, and QSRs
- Maintain deliverable trackers, package status, review comments, and closeout logs
- Support discrepancy/deviation documentation and package completion
- Ensure document consistency across equipment families
- Coordinate with CQV leads, execution engineers, quality reviewers, and project management
- Support final closeout and archival readiness
- Maintain traceability between deliverables, review comments, execution results, and QSRs
Job Requirements:- Bachelor's Degree or equivalent required
- 5+ years GMP documentation, validation documentation, or CQV package support experience
- Experience supporting CQV documentation in pharmaceutical, biologics, or life sciences environments
- Familiarity with URS, IQ/OQ/PQ, readiness checklists, QSRs, deviations, and traceability
- Strong attention to detail and document control discipline
- Experience with ValGenesis or similar validation/document management systems
- Prior large pharma experience
- Experience supporting fast-paced CQV or capital project closeout
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-$108,980 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
