|Client; Engineering company focused on Process Automation delivery of Process Automation Solutions to Global Brands. Distilleries | Breweries | Blending Plants | Food Production | BioPharma.
End client; Pharmaceuticals corporation.
- cGMP and Validated Systems Owner
- Responsible for developing and executing commissioning and qualification documentation for new or modified process systems and equipment. This may include the development of user and function requirements, execution of factory/site acceptance testing, commissioning, and development of design qualifications
- Serves as of contact for validation studies performed by external contractors or vendors, coordinating execution of studies with our clients Manufacturing Operations, Engineering, Utilities and QA personnel as required.
- Support continuous improvement of our client’s facilities and equipment by risk assessing proposed changes to ensure the qualified state is maintained. Generate and execute approved change control test scripts to demonstrate that proposed changes are appropriate and do not impact equipment or process validation.
- Maintain specialist validation equipment in a compliant state, ensuring that raw data is archived appropriately in a GMP compliant data storage system.
- Bachelor’s Degree in engineering or scientific discipline preferred.
- Direct experience performing validation studies in cGMP pharmaceutical industries.
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