6442 - Senior CQV Engineer / Senior Validation Engineer

Veristainc; Harvard (MA); On-site; USD 70,491 - 113,521; Full time

Benefits offered by this job

Competitive pay

Life, Short-Term and Long-Term DI

Medical, Dental & Vision insurance

401(k) Retirement Plan

Paid Time Off and Holidays

Tuition Reimbursement

Job summary

Verista is seeking a Senior CQV Engineer to lead C&Q documentation, supplier coordination, and commissioning for viral vector drug substance processing equipment and single-use systems. The role requires field leadership to manage turnover, IOQ, and final reporting on site in Devens, MA.

You will own system documentation, lead walkdowns, author and review protocols, and coordinate vendor FAT/SAT packages to create robust qualification evidence.

Qualifications

• 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; comfortable with electronic protocol evidence expectations.

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.

Skills

CQV in biologics

Single-use bioreactors

IOQ testing

Documentation/writing protocols

Vendor management

Walkdowns

FAT/SAT review

Education

Bachelor’s Degree

Tools

ValGenesis

Job description

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 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.

Salary Range (US)

$70,491 – $113,521 USD

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 (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

*Verista is an equal opportunity employer.