MES Recipe Author Associate

Author, configure, test, and maintain Electronic Batch Records, including Generic Master Batch Records (GMBR) and Production Master Batch Records (PMBR), utilizing leading MES platforms such as Rockwell PharmaSuite or Werum PAS-X.

Support recipe deployment and lifecycle transitions across multiple validation stages (Dev, Test/QA, Validation, and Production) in strict alignment with formal change control procedures.

Provide Level 2 and Level 3 production support for live MES operations, performing root cause analysis, resolving runtime discrepancies, and ensuring recipe operational integrity.

Execute end-to-end MES recipe validation activities, including test script authoring, IQ/OQ/PQ execution, and formal validation documentation conforming to GAMP 5 and CSV frameworks.

Enforce strict compliance with data integrity principles (ALCOA+), 21 CFR Part 11, EU Annex 11, and current Good Manufacturing Practices (cGMP).

Partner with site Manufacturing Science, Quality Assurance, and Validation teams to align electronic recipe parameters with physical manufacturing batch processes.

Collaborate with global MES deployment engineers, automation architects, and IT operations to support site go-lives, platform upgrades, and recipe promotions across global pharmaceutical manufacturing sites.