Validation Engineer II � CSV & Compliance

Job DescriptionSupport IT/OT system owners with computer system validation (CSV), lifecycle documentation, compliance reporting, and ongoing system maintenance for GMP-regulated manufacturing systems (ISA-95 Level 2 & 3).Responsibilities Perform CSV/CSA lifecycle activities: validation, testing, documentation, and periodic reviews. Create/update and execute validation protocols (IQ/OQ/PQ, test scripts, reports). Support annual system maintenance (MILE) and system audits. Manage QMS records (CAPA, Deviations, Planned Events). Ensure GMP & data integrity compliance during system upgrades/changes. Collaborate with system owners and global stakeholders. Support document management systems and compliance reporting. Mandatory Skills / Requirements: Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 5+ years of CSV experience (GAMP / CSA) in Pharma or regulated industry. Strong experience with ISA-95 Level 2 & Level 3 systems. Hands-on knowledge of FDA 21 CFR Part 11, EU GMP, Annex 11, GxP & Data Integrity. Experience supporting IT/OT manufacturing systems validation and compliance Preferred Skills: Experience with DeltaV, MES, SCADA, OSI-PI, Siemens Desigo, Rockwell FactoryTalk, Client. Experience with Veeva, Condor, eVal Roche or similar DMS tools. MES administration, EBR recipe authoring. Exposure to Level 1 systems. Strong compliance reporting and metrics experience.