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 pharmaceutical industry.

Our client is expanding rapidly and has a small in-house team of design engineers, machinist and welder, control engineers, service engineers and building systems and maintenance engineers. They are looking for a Quality Engineer to join their Quality Assurance department to act as the primary liaison with the engineering team.

You will need a good foundation in engineering disciplines and will be provided training in the relevant pharmaceutical disciplines.

Key responsibilities

• To provide technical, engineering review and input into the design, build and maintenance of equipment and facilities. This includes, but is not limited to:
  
  
  • Providing QA review of User Requirement Specifications, Functional and Design Specifications, FAT and SAT.
    
    
  • Assisting with creating Change Controls.
    
    
  • Assisting with creating, and providing QA review, of calibration certificates generated in-house.
    
    
  • 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).
    
    
  • Providing QA review of engineering Standard Operating Procedures, ensuring the process is as described and suitable.
    
    
  • 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.
  
  Experience & Qualifications
  
  
• MEng in Mechanical, Automotive, Aerospace, or similar. The role requires a broad foundation in understanding of basic engineering disciplines:
  
  
  • Materials and Structures.
    
    
  • Pressure and Flow.
    
    
  • Heat Transfer.
    
    
  • Mechanisms and Control.
    
    
• Specialism in material identification and fractography preferable.
  
  
• Industrial experience as a Quality Engineer and experience with Quality Management Systems