Computer System Validation (CSV)

Must have experience in Computer System Validation / Computer Software Assurance / Quality Compliance within the life sciences industry.

Strong experience working in GxP-regulated manufacturing environments, preferably pharmaceutical, biotechnology, medical devices, or other regulated manufacturing sectors.

Must have Hands-on experience with validation of infrastructure, IT/OT platforms, shopfloor systems, manufacturing applications, or related technology programs.

Strong understanding of CSV lifecycle deliverables including URS/FRS, risk assessment, validation plan, IQ/OQ/PQ, test scripts, traceability matrix, deviation management, and validation summary report.

Good to have Experience supporting technology changes in live manufacturing or production environments where downtime, compliance, and product quality are critical considerations.

Familiarity with change control, incident management, problem management, SOP governance, and audit readiness in regulated environments.

Experience working with global delivery teams, site teams, Quality organizations, and technical SMEs across multiple geographies