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-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: ...