| Location: Switzerland | Salary: + Benefits |
| Sector: Pharmaceuticals | Specialism: |
| Type: Permanent | Contact: Adrienne Kettlewell |
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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