6367 - CQV Documentation Specialist / Project Engineer

Verista, Inc.Devens, MA
$70,491 - $108,980Onsite

About The Position

Verista is 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. Verista's mission is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

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
  • Ability to be on-site, full-time in Devens, MA

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

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
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
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