Pharmaceutical Manufacturing Quality Engineer
Wigston
Up to £55,000 DOE
Summary
This is a unique opportunity for a Quality Engineer to transfer their skillset from more conventional industries, such as Automotive and Aerospace, into an equally regulated industry. SF are looking for a Quality Engineer to join our clients Quality Assurance department to act as the primary liaison with the engineering team. The individual will need a good foundation in engineering disciplines and will be provided training in the relevant pharmaceutical disciplines.
Job Description
- To provide technical, engineering review and input into the design, build and maintenance of equipment and facilities. This includes, but is not limited to:
o Providing QA review of User Requirement Specifications, Functional and Design Specifications, FAT and SAT.
o Assisting with creating Change Controls.
o Assisting with creating, and providing QA review, of calibration certificates generated in-house.
o Creating User Requirement Specifications for the engineering team when the driver is improvement in quality (e.g. to accommodate a change in the pharmaceutical regulations).
o Providing QA review of engineering Standard Operating Procedures, ensuring the process is as described and suitable.
o Providing QA Go/No Go decisions for engineering*.
- To run CAPA clinics for the engineering team to help the team close out overdue actions on QIs and Deviations and help generate and keep updated progress on planned Change Controls.
- To provide Subject Matter Expertise in investigations that requires engineering knowledge, collate supporting information from the engineering team and complete Risk Assessments on the impact of engineering QIs and Deviations.
- To provide technical, engineering review and input to the Validation Team during IQ/OQ.
Qualifications
- MEng in Mechanical, Automotive, Aerospace, or similar. The role requires a broad foundation in understanding of basic engineering disciplines:
o Materials and Structures.
o Pressure and Flow.
o Heat Transfer.
o Mechanisms and Control.
- Specialism in material identification and fractography preferable.
- Industrial experience as a Quality Engineer and experience with Quality Management Systems
- *Additional training will be provided through additional courses, both in-house and third party, on pharmaceutical regulations, pharmaceutical equipment and facility design, and microbiology. It is expected individuals with an MEng or similar will have the technical and scientific ability to undertake these courses.