Senior Computer System Validation Engineer

Job overview

The Senior Computer System Validation Engineer works onsite in Lexington, MA, with an annual salary range of $115,000–$140,000. Genezen develops processes, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials. The engineer leads validation of GxP computerized systems and supports data integrity across laboratory and manufacturing operations. The role helps ensure systems and records meet regulatory requirements and strengthens the company’s Quality Management System and operational practices.

What you'll do

• Lead risk-based validation strategies across system lifecycles
• prepare and oversee validation protocols and documentation
• review and approve qualification documents
• assess system events and data reliability
• support deviations, investigations, CAPAs, and change controls
• develop CSV procedures and templates
• conduct periodic reviews and data integrity assessments
• support vendor qualification, audits, and inspections.

What we're looking for

Skills & competencies

senior csv validation engineer

computer system validation

gxp

data integrity

lexington ma

genezen

gmp

quality management

fda compliance

$115k–$140k

gene therapy

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid vacation and sick time
• observed and floating holidays
• 401(k) match up to 6%
• share appreciation rights
• healthcare plans
• FSA and HSA
• dental and vision
• employer-paid basic life and personal accident insurance
• voluntary disability and other insurance.

Why this role

Seven or more years of computer system validation experience required; knowledge of cGMP, 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, and GAMP 5; visa sponsorship is not available.

About the employer

Genezen is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.