Associate Principal Engineer,Siemens OpCenter

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
• Support MES implementation, integrations, and production issue resolution
• Prepare and manage validation plans and documentation
• Participate in audits, compliance activities, and cGMP requirements
• Support solution design, integrations, and system configurations
• Troubleshoot issues during testing, validation, and deployment