Senior Pharmaceutical Manufacturing System Expert

20 hours ago

Kottayam, Kerala, India beBeePharmaceutical Full time ₹ 20,00,000 - ₹ 26,00,000
Job Description

We are seeking a highly experienced professional with 6-8 years of experience in pharmaceutical manufacturing systems, including technical and functional expertise in MES & L2 systems.

The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) and have prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.

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.

Required Skills and Qualifications

  • 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

Benefits

  • 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

Additional Skills

  • MES system configuration, deployment, and validation.
  • Front-end application troubleshooting and user support.
  • GxP and 21 CFR Part 11 compliance.
  • Validation protocol development and execution (IQ, OQ, PQ, UAT).
  • Documentation management (URS, FS, DS, traceability matrices).
  • Data migration and master recipe creation.

Knowledge of data analytics tools is a plus. Edge Cloud deployment experience with IoT and IIoT is also desired.

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