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Senior MES Engineer (Syncade) - Drug Product

Location: Salary: + Benefits
Sector: Pharmaceuticals Type: Permanent
Contact: Adrienne Kettlewell Job Published: 28 days ago

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.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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