Senior Pharmaceutical Systems Specialist

1 week ago

Amrāvati, Maharashtra, India beBeeManufacturing Full time ₹ 9,00,000 - ₹ 12,34,567
Pharmaceutical Manufacturing Systems Expert

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. The successful candidate will be responsible for supporting the implementation of the Manufacturing Execution System (MES) & L2 at our manufacturing sites.

This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution. The ideal candidate will also be accountable for leading site-level validation activities and technical owner responsibility, and managing all GxP documentation related to the MES & L2 system.

The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements.The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live.

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:

  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Master's 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, 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:

  • 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.

Additional Qualifications:

  • Knowledge of data analytics tools.
  • Edge Cloud deployment experience with IoT and IIoT.
  • L2 integration with MES.
  • MES integration with SAP.
  • Understanding of network and databases.

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