Senior Pharmaceutical Automation Expert

1 day ago

Aurangabad, Maharashtra, India beBeeExpert Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Description:

We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in manufacturing execution systems (MES) and level 2 systems. The ideal candidate will ensure adherence to global regulations, such as FDA 21 CFR Part 11, EU GMP, and GAMP5.

  • 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 good documentation practices (GxP), including user requirements specifications, functional specifications, design specifications, 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.

Educational Qualification : 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.

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

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 (Functional & Behavioural): Functional: 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. Behavioural: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Detail- oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments

Additional 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

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