Manager, MES & PI Systems

About the role

Ancillary support to internal and external audits, inspections, and data integrity assessments.

What you'll do

• Serve as System Owner for Manufacturing Execution System (MES) and PIHistorian, ensuring reliability, data integrity, and continuous GMP compliance
• Execute configuration and system changes under formal change control to optimize performance while maintaining validated state
• Ensure system documentation, configuration records, and validation deliverables remain inspection-ready at all times
• Maintain alignment with global computer systems validation (CSV) and Annex 11 / 21 CFR Part 11 requirements

What you need

• Compliance
• GMP
• Documentation
• Any graduate