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Strong Big4 brand but niche CSV/GxP specialization reduces applicant density.
Requires domain-specific CSV/GxP/regulatory expertise, limiting cross-industry transferability.
Explicit 4–12 years plus mandatory CSV/GxP validation deliverables and regulatory experience.
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Lead Computer System Validation (CSV) activities including authoring key validation deliverables (e.g., Validation Plans, URS, FRS, IQ/OQ/PQ protocols).
Conduct manual software testing and defect tracking within SDLC and STLC frameworks, including Waterfall, Agile, and V model.
Ensure compliance with regulatory standards such as GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
4 to 12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree mandatory.
Knowledge of SDLC methodologies including Waterfall, Agile and CSV V model.
Experience with GAMP5 guidelines, GxP, FDA 21 CFR Part 11, EU Annex 11, including change control and deviation management.
Experienced in creating and managing comprehensive CSV documentation and deliverables.
Familiar with multiple software testing techniques such as Positive/Negative Testing, Regression Testing, and Smoke/Sanity Testing.
Comfortable operating within regulated environments and capable of applying compliance standards in IT systems validation.