About the role
You will be embedded with a global medical device manufacturer in India operations, driving MES configuration, business process alignment, and system lifecycle governance on Siemens Opcenter. This is a senior individual contributor role with direct client engagement and delivery accountability.
Responsibilities:
- Lead end-to-end MES configuration and functional design on Siemens Opcenter Execution.
- Own requirements gathering, FDS and URS documentation, and workshop facilitation with plant stakeholders.
- Configure and maintain container types, transaction flows, attribute sets, eBR modules, and genealogy and traceability setups.
- Support and oversee Computer System Validation (CSV) activities, including IQ, OQ, and PQ protocol review and execution.
- Ensure all configurations meet 21 CFR Part 11 compliance standards, including audit trails, e-signatures, and change control.
- Drive MES ERP integration coordination with SAP or Oracle and support equipment integration scoping.
- Serve as an SME bridge between business users, IT, and validation teams.
Requirements:
- 8 to 10 years of MES experience with a minimum of 4 years of hands-on Siemens Opcenter Execution or Camstar.
- Demonstrated experience in medical device, pharma, or life sciences manufacturing environments.
- Functional depth in: Work Order Management, Genealogy, Electronic Batch Records (eBR), Shop Floor Execution, and MES Modeling.
- Working knowledge of CSV principles and participation in at least one IQ, OQ, and PQ cycle.
- 21 CFR Part 11 or equivalent GxP compliance exposure.
- Strong client-facing skills, including requirements documentation, stakeholder workshops, and formal change management.
Good to Have:
- Mendix Development or Configuration Experience.
- SAP PP Integration.
- SAP MM Integration.
- Oracle Manufacturing Integration.
- Equipment / SCADA Integration.
- OPC UA Interfaces.
- UAT and SIT Testing.
- Siemens Opcenter Intelligence Analytics Module.