Computer System Validation Engineer
Core
Develop and execute Computer System Validation (CSV) protocols and test scripts for Life Sciences and Mission Critical industries, ensuring compliance with GxP and 21 CFR Part 11.
Role type
Computer System Validation Engineer
Builds
GxP compliant computer validation documentation and test results for filling lines and automation systems
Domain
Life Sciences / Pharma / Biotech / Medical Device
Required skills
Computer System Validation (CSV), GxP compliance, 21 CFR Part 11, GAMP, Data Integrity, aseptic process knowledge, filling line automation, MES systems, SCADA/PLC platforms
Preferred skills
Biotech and pharma industry experience, Data Integrity (483, consent decree), specific automation platforms (Rockwell, GE, Siemens, etc.)
Responsibilities
Develop and execute CSV protocols and test scripts, identify validation gaps, consult on and direct plans for resolution, write GxP validation documentation (assessments, plans, URS, FRS, RTM, summary reports)
Seniority
Mid-level (2-7 years experience)