Assignment Details
Our client, a Leading Indian Biopharmaceutical Company, is seeking to engage with a IT Product Manager to define the roadmap and lead the Implementation of Manufacturing Execution System (MES) for Biologics Manufacturing facilities globally (India and Malaysia).
Key Responsibilities:
- Collaborate with Business operations, Engineering, Quality units and other
stakeholders to understand the existing IT systems and derive road map
- Further collaborate with Vendors to finalize the scope of implementation
- Be the IT representative in MES implementation core team as IT System Owner/Product Manager for MES
- Lead the MES Interface & integrations with 3rd party applications (ERP, LIMS, VLMS, Equipment Calibration, Maintenance Systems, PLM, SCADA systems and IIOT)
- Review and approve MES Validation deliverables
- Engaging with manufacturing users, product admins, and site leads and conduct MES Product training workshops and facilitation across a range of stakeholders.
- MES application change management and Continual improvement
Skills Required
- Minimum 10 years of Industry experience (at least 5 years in Pharma or Biopharma industry)
- Implemented and change managed MES application at least in two manufacturing units. As part of core implementation team.
- Knowledge of informational and operational technologies (IT/OT), MES integration to enterprise systems.
- Very good knowledge of SDLC and Software Validation
- Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
- Hands-on Configuration experience in handling designing solution in Manufacturing application like MES, Operations support systems and integrations.
- Experience in handling Werum/ PAS-X or Rockwell MES along with integration with SAP is an added advantage.
- Prior experience in working closely with IT/OT providers/vendors
Share
8 month(s)
10+ years 
Hybrid
