Digital Manufacturing Systems Specialist

4 days ago

Chennai, Tamil Nadu, India beBeeManufacturing Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Digital Manufacturing Systems Specialist

We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.

This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

The successful candidate will lead site-level validation activities, manage all GxP documentation related to the MES & L2 system, and serve as the go-to authority for end-to-end MES product knowledge.

This includes a deep understanding of system functionality, configuration, and compliance requirements.

The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5).

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:

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

Certifications:

  • 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

Experience:

  • 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

Skill:

  • 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

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