Job Description
Job Description
REQUIREMENTS
9+ years of experience in Pharma / Biotech MES implementationsHands-on experience with Siemens Opcenter and recipe authoring (mandatory)Experience in EBR design, MBR development, and S88 standardsStrong knowledge of GxP, CSV, and 21 CFR Part 11Understanding of pharmaceutical manufacturing processes and biotechnology productsExperience in validation activities (IQ, OQ, PQ, RTM), risk and gap analysisExposure to MES integrations and solution architectureStrong communication, documentation, and stakeholder management skillsExperience leading teams or complex projects is preferredRESPONSIBILITIES
Conduct discovery workshops, requirement gathering, and process analysisDesign recipes, workflows, and Electronic Batch Records (EBR) aligned with MBR and S88Execute dry runs, testing, and validation before Go-Live
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