6367 - CQV Documentation Specialist / Project Engineer

United States·Devensmid

OtherDocumentation Specialist

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Quick Summary

Key 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,

Requirements Summary

Support generation, formatting, routing, tracking, and closeout of CQV deliverables Support URS revisions, readiness checklist packages, IOQ/PQ packages, and QSRs Maintain deliverable trackers,

Technical Tools

OtherDocumentation Specialist

Description

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

Responsibilities

~1 min read

→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

Requirements

~2 min read

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

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For more information about our company, please visit us at Verista.com