£35000 - £40000 per annum + Benefits
We are a global pharmaceutical company specialising in the development of products targeting cancer, critical care and other disorders.
Due to continued growth we have an amazing opportunity for a Process Engineer to join the team.
You will be working within manufacturing providing technical expertise and process knowledge to the manufacturing teams and improving efficiency, effectiveness and the success of manufacturing and supply operations.
Acting as the subject matter expert to support delivery of medium to long term projects Use technical expertise and influence to identify opportunities for process improvement projects for medical device and drug device combination products. Provide expert technical/process knowledge and investigation expertise for significant quality events in all areas of the manufacturing process. Lead identification of root cause and implementation of effective CAPAs; ensuring delivery is completed in a compliant matter. Implementation of change controls for process or equipment changes within Manufacturing. Lead and manage the process of technical transfers (including process development, scale up and new product introduction) from development to manufacturing and between sites/companies. *Support validation activities for commercial manufacturing to ensure that processes are maintained in a validated and compliant state.
Education and Experience
Must: Educated to degree level in Mechanical/Chemical/Process Engineering, or with significant medical device and/or pharmaceutical industry experience supported by alternative qualifications. Experience of Manufacturing or Product Development in the Pharmaceutical and/or Medical Device industry (other highly regulated and quality driven industries may be considered).
Desirable: Lean Six Sigma Green Belt Accredited Knowledge of cGMP, ISO13485, 21CFR 820 and other relevant regulatory requirements. Project management experience/qualification (e.g. Prince2) would be advantageous. Demonstrated experience in delivering new equipment/processes into manufacturing, through sourcing, development, qualification to commercialisation. *Demonstrated experience in existing process and equipment optimisation and validation.
Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.
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Posted 26 days ago