System Implementation and Validation Professional

12 hours ago

Thrissur, Kerala, India beBeeImplementation Full time ₹ 20,00,000 - ₹ 25,00,000
**Job Title:** System Implementation and Validation SpecialistWe are seeking an experienced professional with a strong background in pharmaceutical industry operations, including MES and L2 systems. The ideal candidate will ensure adherence to global regulations.**Key Responsibilities:
  • Representing site-specific needs during MES design, configuration, and deployment.
  • Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
  • Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
  • Maintaining deep knowledge of MES functionality and architecture.
  • Acting as the first point of contact for MES application issues and user support.
  • Delivering training and ensuring user readiness for MES usage.
  • Supporting data collection, migration, and master recipe creation.
  • 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
  • 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
  • 6 to 8 years of experience
  • Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements.
  • MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.
  • Validation Expertise: Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
  • Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment.
  • Audit Experience: Familiarity with audit processes and documentation expectations
**Desirable Skills:
  • Knowledge of data analytics tools
  • Edge Cloud deployment experience with (IoT and and IIoT)
  • L2 integration with MES
  • MES integration with SAP
  • Understanding of network and databases
**Qualification Requirements:** Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.**Specific Certification:** GAMP 5 for system validation in regulated environments.

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