
Senior Pharmaceutical MES Technical Lead
2 weeks ago
The Site MES Project Expert is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.
Main Responsibilities:
- MES Implementation: Representing site-specific needs during MES design, configuration, and deployment.
- Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
- Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
- MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
- Front-End Support: Acting as the first point of contact for MES application issues and user support.
- Training & Adoption: Delivering training and ensuring user readiness for MES usage.
- Data Management: Supporting data collection, migration, and master recipe creation.
- Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready.
Requirements:
- 6 to 8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.
- Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
- Preferred: Masters degree with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields.
- Specific Certification: GAMP 5 for system validation in regulated environments, CSV (Computer System Validation) for compliance with GxP, MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell, 21 CFR Part 11 Compliance Training for electronic records and signatures.
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