Computer System Validation (CSV) Engineer
Core
Lead lifecycle validation of computerized systems (automation, DBR, DCS, BMS, FMS) in regulated pharmaceutical, biotech, or medical device manufacturing to ensure data integrity and regulatory compliance.
Role type
Senior Computer System Validation (CSV) Engineer
Builds
Validated computerized systems for automated production and facility control
Domain
Regulated pharmaceutical/biotech/medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
GAMP5 methodology, PLC/HMI validation (Siemens/Rockwell), BMS validation (Honeywell EBI), environmental monitoring software validation, Change Control, Deviation Management, Risk Management, GxP/GAMP5/Annex 11/FDA 21 CFR Part 11 compliance, ALCOA+ data integrity assessment, root-cause analysis, CAPA management
Preferred skills
Experience with NoMA/Statens legemiddelverk or FDA audits
Technologies
Siemens PLC, Rockwell HMI, Honeywell EBI BMS, FMS
Responsibilities
Lead validation lifecycle activities for automated production equipment and facility systems; Author and execute IQ/OQ/PQ protocols; Ensure compliance with GxP, GAMP5, Annex 11, and FDA 21 CFR Part 11; Conduct ALCOA+ data integrity assessments on PLCs, HMIs, and environmental monitoring databases; Support internal and external regulatory inspections as CSV subject matter expert; Partner with automation, IT, and Quality teams to execute system changes via Change Control.
Seniority
Senior, hands-on IC
