Process Engineer - Pharma
Our International Pharmaceutical Manufacturing Client is looking for a Process Engineer to join their busy team.
Your role will be to work within manufacturing as part of the Manufacturing Technical Support function; provide technical expertise in their specialist field to deliver improvement projects and new product introductions, to increase the efficiency, effectiveness and success of Manufacturing and Supply Operations.
- Acting as subject matter expert to support delivery of medium to long term projects; to ensure availability of capacity and capability to meet commercial demand.
- Use technical expertise and influence to identify opportunities for process improvement projects for medical device and drug device combination products. Complete implementation through generation of data/technical justification, implementation and qualification.
- 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. Ensure that actions are tracked for compliance and delivery in line with agreed plans and provide regular updates/feedback to key stakeholders to ensure visibility of project progress is maintained.
- Support validation activities for commercial manufacturing to ensure that processes are maintained in a validated and compliant state.
- Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished in accordance with the Client’s values.
- Carry out other reasonable tasks as required by the Line Manager.
Education and Experience
- Educated to degree level in Mechanical/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 (some other highly regulated and quality driven industries may be considered).
Accountable to – MTS Lead, Technical Manager, Engineering Technical Service, Production Team, Quality Team, Innovation Scientists and Engineers