CSV Engineer
Core
Develop and execute Computer Systems Validation (CSV) protocols and test scripts for GxP and 21 CFR Part 11 compliant computerized systems in Life Sciences and Mission Critical industries.
Role type
Senior IC CSV Engineer
Builds
Validated computerized systems and operational readiness for Life Sciences and Mission Critical clients
Domain
Life Sciences / Pharma / Biotech / Medical Device / Industrial Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), GxP compliance, 21 CFR Part 11, GAMP, Data Integrity, Change Control Management, URS/FRS/RTM documentation, Regulatory Audit preparation, Project Management, Troubleshooting, Vendor/Contractor coordination
Preferred skills
Biotech/Pharma industry experience, MES/Delta V/PI system experience, Rockwell/GE/Emerson/Siemens platform experience, Medical Device industry experience
Technologies
MES, Delta V, PI, Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware
Responsibilities
Develop and execute CSV protocols and test scripts; Write GxP and 21 CFR Part 11 documentation (assessments, plans, URS, FRS, RTM, reports); Manage change controls and compliance tasks; Analyze test results against criteria; Investigate and troubleshoot system problems; Coordinate with departments and vendors; Participate in regulatory audits; Assess systems for Part 11/Annex 11 gaps; Supervise lower-level personnel
Seniority
Mid-to-Senior, hands-on IC with potential leadership
