Computer System Validation Engineer

Job overview

The Computer System Validation Engineer role is onsite in Woburn, MA. Compensation is not specified. The engineer supports validation of QC laboratory and manufacturing systems in GMP-regulated pharmaceutical or biotechnology environments. The role develops and maintains validation documentation and protocols across the system lifecycle, helping ensure systems meet regulatory and internal quality requirements. Collaboration with quality, manufacturing, engineering, and IT teams supports compliant system implementation and ongoing operation.

What you'll do

• Develop, execute, and maintain CSV documentation and protocols
• prepare and review URS, IQ, OQ, PQ, risk assessments, and validation reports
• assess and mitigate validation risks
• ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal standards
• support change control, deviation investigations, periodic reviews, and inspections
• maintain audit-ready records.

What we're looking for

Skills & competencies

computer system validation engineer

woburn ma

karwell technologies

csv

gmp

gamp 5

21 cfr part 11

qc laboratory systems

manufacturing systems

validation protocols

risk assessments

regulatory compliance

Work arrangement

• Weekend coverage required

Why this role

Requires experience in CSV within a GMP-regulated pharmaceutical or biotechnology environment and hands-on support for QC laboratory systems and/or manufacturing equipment validation.

About the employer

Karwell Technologies is hiring for this role. Industry: Engineering Services. Sector: 54.