The successful applicant will work as part of a technical team focused on marketed product support, new product introduction and continuous improvement activities for both Class 1 Medical Devices and Pharmaceutical Products.
Responsibilities include:
- Partake in technical activities for the MT Team to ensure technical development of manufacturing products and processes.
- Further develop product and process understanding for the value stream manufacturing processes.
- Provide ongoing support for the product / process, including training, troubleshooting, continuous improvement projects, annual product reviews etc.
- Prepare and execute Validation Master Plans, Product Optimisation Studies, Product Validation and Cleaning Validation Documents.
- Champion continuous improvement within the production teams.
Knowledge and skills required:
- Experience in GMP within a contract manufacturing environment of Medical Devices and Drugs or similar regulated environment is strongly preferred.
- Lean Six Sigma Green Belt trained preferred but not essential.
- Process optimisation techniques.
- Product Validation.
- Continuous Improvement Techniques including Lean Manufacturing / Six Sigma concepts.
- Familiarity with Medical Device and Drug Product Quality Systems and GMPs for EU, US and ROW:ISO13485, Eudralex / Orange Guide.
Qualifications:
- Educated to degree level or equivalent in a relevant science or engineering discipline.
- Relevant work experience within a field of medical device and the drug production industry is preferred.
Full details available upon application.
