Computer Systems Validation (CSV) Engineer
Core
Implementing Computer System Validations and managing the lifecycle of computerized systems to ensure compliance with GxP regulations for medicine manufacturing.
Role type
Computer Systems Validation (CSV) Engineer
Builds
Validated computerized systems for manufacturing and laboratory operations
Domain
Life sciences / Pharmaceutical manufacturing / Regulatory compliance
Deliverable
client delivery
Required skills
Computer System Validation (CSV), GxP regulations, GAMP5, Data Integrity principles, Validation methodologies, Regulatory authority requirements (FDA, MHRA)
Preferred skills
Managing multiple projects, Continuous improvement, Solution-oriented mindset
Technologies
GAMP5, Eudralex Volume 4 Part 11, 21 CFR Part 11
Responsibilities
Leading full lifecycle validation for manufacturing and laboratory systems, Writing validation plans and protocols (IQ, OQ, PQ), Performing periodic reviews to maintain validated state, Preparing CSV work instructions and audit logbooks, Compiling and maintaining CSV documentation, Working with process owners to implement new systems, Participating in internal and external audit inspections
Seniority
Mid-level, hands-on IC
