Manufacturing Systems Expert

• Define User requirement specifications (Voice of customer)
• Design and create electronic batch files (EBR) with respect for quality, costs and deadlines
• MBR / BOM/ 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

What you ll bring to the role:

• * Minimum 5 year experience in GMP manufacturing process support role Proven experience in MES expert role
• * University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience
• *Competencies Good scientific and technical (automation) understanding Deep process understanding
• *Quality and compliance skills
• *Team player with strong team spirit
• * Change management, adaptability, ability to work under pressure
• * Mastering of automation and computer skills
• *Good understanding of regulatory requirements across multiple health authorities
• *Mastering of manufacturing execution systems (MES, SAP, or other as applicable)
• * Good office software applications