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Big Four brand increases applicants, but niche CSV/GxP skills moderately limit candidate pool.
Requires GxP/CSV regulatory expertise, limiting transferability across non-regulated industries.
Explicit 4–12 years plus mandatory CSV, GxP and validation deliverables create strict screening filters.
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Own end-to-end Computer System Validation (CSV) processes including authoring validation deliverables (e.g. Validation Plan, URS, FRS, IQ/OQ/PQ protocols).
Conduct manual software testing (positive/negative, regression, smoke, sanity) and defect tracking in compliance with GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Apply knowledge of Software Development Life Cycle (Waterfall, Agile) and Software Testing Life Cycle methodologies to ensure IT compliance in regulated environments.
4-12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree.
Working knowledge of GAMP5 guideline, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and change control procedures.
Experience in manual testing methods and creation of CSV deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols.
Experienced in managing CSV activities within regulated pharmaceutical or life sciences environments with hands-on testing and validation expertise.
Familiarity with SDLC methodologies (Waterfall, Agile, V model) and software testing tools; knowledge of CSV-specific tools like Valgenesis is a plus.
Capable of authoring and reviewing detailed validation documents and applying risk-based assessments (FMEA) for compliance and audit readiness.