Job Description

Job Description

REQUIREMENTS

  • 9+ years of experience in Pharma / Biotech MES implementations
  • Hands-on experience with Siemens Opcenter and recipe authoring (mandatory)
  • Experience in EBR design, MBR development, and S88 standards
  • Strong knowledge of GxP, CSV, and 21 CFR Part 11
  • Understanding of pharmaceutical manufacturing processes and biotechnology products
  • Experience in validation activities (IQ, OQ, PQ, RTM), risk and gap analysis
  • Exposure to MES integrations and solution architecture
  • Strong communication, documentation, and stakeholder management skills
  • Experience leading teams or complex projects is preferred
  • RESPONSIBILITIES

  • Conduct discovery workshops, requirement gathering, and process analysis
  • Design recipes, workflows, and Electronic Batch Records (EBR) aligned with MBR and S88
  • Execute dry runs, testing, and validation before Go-Live
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