6367 - CQV Documentation Specialist / Project Engineer

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business 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. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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. *Verista is an equal opportunity employer. National (US) Range

$70,491 — $108,980 USD

Benefits Why 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 Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com #J-18808-Ljbffr Socket.dev