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Senior CSV Validation Engineer

Genezen · Lexington, MA

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Level
Senior
Team
Quality
Base pay
$115k–$140k
Degree
Required
Experience asked
7+ years
Industry
Pharma & life sciences
Posted
30+ days ago

The role in 30 seconds

A senior quality role at Genezen (pharma & life sciences) in Lexington, MA. Evaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards.

They ask for
7+ years · degree required
Tools it names
FDA / GMP, Validation (IQ/OQ/PQ)
Base pay
$115k–$140k

Read from the posting. The full description is below.

From the plant jobs report · week of October 19, 2026

Quality Engineer roles in Massachusetts: typical posted base $97k–$131k. This one lists $115k–$140k.

Median of the low and high ends of 36 live postings that list pay, out of 55 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.

Massachusetts plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 54 other live quality postings in Massachusetts.

Base pay
About 12% above similar roles

Typical $97k–$130k, from 35 postings that list pay.

Experience asked
More than usual (7+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 75%
  • ✓ FDA / GMP 56%
  • ✓ Validation (IQ/OQ/PQ) 56%
  • ISO 13485 51%
  • CAPA 49%
  • FMEA 45%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 7+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

At a glance

Promotion path mentionedLifts up to 10 lbs

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Genezen

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: Genezen in Lexington

7 other open roles at this site.

All 8 roles at Genezen →
Full description from GenezenAs posted on their careers site.Show

Job summary

The incumbent is responsible for leading computerized systems validation projects and supporting the data integrity program. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Key deliverables are preparation of relevant documentation (Validation Plans, User

Requirements

Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory

requirements

for new and existing products. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best‑in‑class validation practices that support our Quality Management System and operational excellence.

JOB

Responsibilities

  • ◆Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP software applications
  • ◆Review and approve qualification documentation on behalf of the validation function
  • ◆Evaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards
  • ◆Assess the impact of system-related events on the system’s validated state and data reliability.
  • ◆Lead validation execution and ensure testing is appropriately documented
  • ◆Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls. Serve as initiator and owner of validation related change controls and corrective and preventative actions
  • ◆Develop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practices
  • ◆Support the execution and generation of formal risk assessments
  • ◆Support and conduct periodic reviews
  • ◆Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival
  • ◆Support risk-based Data Integrity Assessments and the audit trail review process
  • ◆Identify data integrity risks and partner with system owners to implement remediation plans
  • ◆Provide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention.
  • ◆Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation

requirements

  • ✓Promote a strong data integrity culture across GxP functions
  • ✓Support audits and regulatory inspections in representing CSV, as needed

Requirements

  • ✓Adaptability required as work schedule may change based on business needs
  • ✓Criminal background check required
  • ✓Other duties as assigned

Education / certifications / licenses

  • ✓A minimum of a bachelor’s degree in Engineering, Computer Science or related discipline

On-the-job experience

  • ✓7+ years of Computer System Validation experience
  • ✓Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems.
  • ✓Demonstrated experience developing and executing risk-based CSV strategies
  • ✓Experience with computerized system periodic reviews
  • ✓Experience with audit trail and data integrity assessments
Show full description ↓

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Working at genezen

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

Skills / abilities

  • •The ability to communicate effectively with employees of all experience levels from Genezen and other contract firms
  • •The ability to report on project activity in a clear and concise manner
  • •The ability to communicate and work effectively with fellow project team members
  • •Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • •Understanding of cGMP regulations
  • •Strong technical writing skills
  • •Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
  • •Strong project management skills with the ability to manage multiple activities with challenging timelines
  • •Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines

Physical demands

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • •Regularly sit for long periods of time.

Movement

  • •Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
  • •Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • •Frequently lift and/or move up to 10 pounds
  • •Rarely lift and/or move up to 25 pounds

Vision

  • •Frequently utilize close vision and the ability to adjust focus

Communication

  • •Frequently required to communicate by talking, hearing, using telephone and e-mail

Genezen's cures value-based competencies

C ommitted to Science

We are committed to scien

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