Validation Engineer - MES - United States
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- Enterprise System Partners is looking for a MES Validation Engineer.
- Develop validation documents for site implementation of Global MES PAS/X Template
- Develop and execute test plans, protocols and procedures
- Develop site test plans as required (Application, ERP, Content etc)
- Develop and support the execution of site testing documents (Application, ERP, Content etc)
- Review of all test scripts/results: IQs/SATs/UAT/Integration
- Planning and execution of validation activities for MES testing (e.g. R1.0.1 and ERP Integration, MBR development and deployment)
Desired Skills & Experience
- BSc / BEng degree in a technical field, Engineering, Chemistry, or IT preferred
- Werum PAS|X experience is a must.
- Experience in a cGMP environment a plus.
- Excellent technical writing and communication skills
- Minimum of three years’ experience in a highly automated medical device or pharmaceutical environment
- Experience of generating and executing system protocols
- Knowledge of FDA and GMP guidelines