Manufacturing System Expert

Key Responsibilities:

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

Essential Requirement:

* 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