Validation Engineer II – CSV & Compliance

Job Description:
Support IT/OT system owners with computer system validation (CSV), lifecycle documentation, compliance reporting, and ongoing system maintenance for GMP-regulated manufacturing systems (ISA- Level & ).
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.
• + years of CSV experience (GAMP / CSA) in Pharma or regulated industry.
• Strong experience with ISA- Level & Level systems.
• Hands-on knowledge of FDA CFR Part , EU GMP, Annex , 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 systems.
• Strong compliance reporting and metrics experience.