Senior Computer System Validation (CSV) Engineer

Job overview

The Senior Computer System Validation (CSV) Engineer works onsite in Albany, NY. Compensation is not specified. The role supports validation of computerized systems used in regulated pharmaceutical, biotechnology, or medical-device environments. The engineer leads risk-based validation across system lifecycles to help ensure compliant deployment and reliable data integrity. Collaboration with IT, quality assurance, engineering, and business stakeholders supports regulatory readiness and effective system changes.

What you'll do

• Lead and execute CSV activities for GxP-regulated systems
• develop and review validation plans, user requirements, functional and design specifications, risk assessments, IQ/OQ/PQ protocols, and summary reports
• ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP requirements
• oversee validation of LIMS, ELN, MES, ERP, CDS, and laboratory systems
• support implementations, upgrades, and decommissioning
• assess change-control and validation impacts
• support data integrity
• provide documentation for audits and inspections
• mentor junior engineers
• improve validation processes and standards
• review vendor documentation.

What we're looking for

Skills & competencies

senior csv engineer

computer system validation

gxp

fda 21 cfr part 11

eu annex 11

gamp 5

lims

mes

erp

data integrity

regulatory compliance

albany ny

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor's degree in engineering, computer science, life sciences, or a related field and 5–10 years of CSV or validation engineering experience in regulated industries. Experience with LIMS, MES, ERP, or laboratory systems and regulatory audits is required; LabWare, SAP, Oracle, Veeva, TrackWise, and Empower experience is preferred.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.