Technical Lead for Pharmaceutical Manufacturing Systems

7 days ago

Palakkad, Kerala, India beBeeImplementation Full time ₹ 1,20,00,000 - ₹ 1,60,00,000
Pharmaceutical MES Implementation Specialist

We are seeking a seasoned IT professional with 6-8 years of experience in pharmaceutical manufacturing, MES or digital systems, validation expertise, application support, and audit experience.

Job Description:
  • 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.

The ideal candidate will have strong analytical and problem-solving skills, excellent communication skills, and the ability to work effectively in a team environment.

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