Roles & Responsibilities:
- Define User requirement specifications (Voice of customer)
- Design and create electronic batch Records (EBR) with respect for quality, costs and deadlines
- Recipe creation in production IT systems
- Participate in the qualification and risk assessment processes
- Propose and technically validate the choice of solutions proposed by the IT teams and Automation in collaboration with the Quality team
- Participate to the deployment of MES across the manufacturing units, runs performance qualification and validation batches (commissioning of the line) with the manufacturing units
- Responsible for the manufacturing documentation update following the implementation of electronic batch files
- Provide training for MES users in partnership with the training team
- Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations
- Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions
- Ensure the transfer of information to production teams following issues or modifications having a technical, quality or HSE impact
- Responsible for MES / MIS technical knowledge transfer to the shop floor
- Ensure the preparation of audits and inspections for related topics
- Collaborate with process experts in the context of deviations related to MES / MIS and continuous process improvement
- Participate to change management in close collaboration with change champion and P&O partner
- Ensure the application of local rules, procedures and policies for the site setup
Requirements:
- 4-6 years’ experience in a similar role, ideally in the Pharmaceutical industry.
- Exposure to Life Science manufacturing business process mapping and recipe authoring Subject matter expert for MES production IT systems
- Experience in User Requirement gathering, Recipe design, OSI-PI, interface with SAP and Trackwise
- Experience with OSI PI system
- Understanding of Pharmaceutical or Biopharmaceutical process
- Understanding of L2 interfaces and integration with MES
- Familiarity with SDLC and quality management processes in the pharma
- Able to support and troubleshoot as Level 1 support.
