
Senior Pharmaceutical Systems Manager
21 hours ago
This role is responsible for overseeing the successful implementation of the Manufacturing Execution System (MES) and L2 at the site.
The ideal candidate will have 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in MES & L2 systems.
Key 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:
- Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
- Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) 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.
The IT Manager plays a vital role in supporting the successful implementation of the MES & L2 system. This includes representing site-specific needs during MES design, configuration, and deployment, as well as managing GxP documentation and leading validation activities. The ideal candidate will have a strong background in engineering, computer science, or a related field, and will be certified in GAMP 5 and CSV. Additionally, they should have experience with MES platform certifications and 21 CFR Part 11 compliance training. If you are a motivated and detail-oriented professional looking to make a meaningful impact in the pharmaceutical industry, this could be the perfect opportunity for you.
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