Pharmaceutical Manufacturing Specialist

1 day ago

Kollam, Kerala, India beBeeManufacturing Full time ₹ 25,00,000 - ₹ 40,00,000

Job Title: Pharmaceutical Manufacturing Expert

Job Description:

Our organization is seeking a seasoned pharmaceutical manufacturing professional to serve as a key functional and technical expert for our MES & L2 system.

The ideal candidate will be responsible for ensuring adherence to global regulations, possessing a deep understanding of system functionality, configuration, and compliance requirements.

Key Responsibilities Include:

  • 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

6 to 8 years of experience in the pharmaceutical manufacturing industry.

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.
Skills Required for Success:

Strong communication skills, proactive problem-solving and risk management, high attention to detail and compliance mindset, ability to work under pressure and manage multiple priorities.

Desirable additional skills include Knowledge of data analytics tools, Edge Cloud deployment experience, L2 integration with MES, MES integration with SAP, Understanding of network and databases.

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