Senior MES Engineer (Syncade) - Drug Product

Senior MES Engineer (Process Expert Syncade)

Senior MES Engineer (Process Expert Syncade) required for my industry-leading client based in Visp, Switzerland. As an experience MES Engineer you will have a strong background in Emerson Syncade and have process knowledge in the area of sterile drug products. You must be comfortable working in a regulated environment, with knowledge of cGMP, 21CRF part 11 and validation requirements.

The key responsibilities of the Senior MES Engineer are:

• Design, author and adapt MES/PCS recipes based on the Drug Product processes
• Coordinate multiple stakeholders to collect recipe inputs
• Define the overall concept for MES recipes used in Drug Product Operations to enable an easy and fast creation as well as adaption to new customer products
• Create and maintain relevant GMP documents (Installation Qualification, Operational Qualification, Performance Qualification, SOP's, etc.)
• Plan, prepare and execute qualification and validation activities
• Provide front line MES support, working with the manufacturing teams (operators), plant engineers and QA operations
• Lead MES related changes, CAPAs, and CAPA effectiveness checks within required timelines and through GMP systems (e.g. Trackwise)
• Provide MES training for all end users
• Plan, prepare and execute MES related improvement and innovation projects
• Act as MES Subject Matter Expert during customer audits and visits, maintain MES at inspection readiness level and provide the necessary support
• Contribute to future projects (e.g. additional filling lines) as MES Subject Matter Expert

Key requirements of the Senior MES Engineer are:

• Knowledge of PCS is preferable, ideally in Emerson DeltaV
• Familiar with working in regulated environment, knowledge of cGMP, 21CRF part 11 and validation requirements
• High proactivity/initiative and independence to lead assigned tasks from start to finish
• Exceptional organisational skills, self-management and ability to work independently
• Very good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
• Ability to handle multiple complex tasks at the same time and under time pressure

**Must be an EU Passport holder or have work rights for Switzerland**

This really is a fantastic opportunity for a Senior MES Engineer to progress their career and support the growth of a global leader. Don't miss out - register your interest in this role with me now.

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