Process Engineer – Pilot Line Production

  Bedfordshire
  Full-time
  Salary dependent on experience
  Permanent

 

About the Client

Would you like to be at the forefront of medical innovation by finding unique solutions for optimising products and processes whilst scaling a pilot line through to manufacture?

We have an exciting permanent opportunity to join a rapidly growing engineering and development company’s R&D department who specialize in POC diagnostic devices that can test for bloodborne diseases.

Our clients are industry leading innovators with a mission to transform community-based healthcare through point of care (POC) diagnostics and make lab-comparable tests accessible to all.

 

About the Role

As a Process Engineer, you will lead a small team in the manufacturing of prototype diagnostic test strips and drive process engineering improvements across all pilot line equipment & processes. You will be responsible for the technical leadership of the team as well as the continuous development of the pilot line manufacturing.

 

Responsibilities include:
  • Driving pilot line manufacturing to ensure delivery against the specifications and timelines of multiple assay development projects.
  • Establishing robust Critical To Quality (CTQ) elements, implementing statistical process controls and deploying across the Pilot Line; driving process, equipment & method improvements and team members to achieve CTQ targets.
  • Developing vision inspection and other methods to inspect to CTQ’s, carrying out Test Method Validations (TMVs) where needed on inspection methods to demonstrate robustness.
  • Working with assay teams (R&D teams developing the new assays) and driving test strip design improvements into the Pilot Line.
  • Reporting on statistical analysis and trends.
  • Managing and developing members of the manufacturing team such that they are motivated and developed to meet the needs of their role to reach their potential.
  • Ensuring regular scheduling and maintenance periods with the manufacturing team to ensure manufacturing processes are prepared to meet the needs of the site.
  • Managing material supplies and incoming stock management.
  • Establishing a strong working relationship with the assay teams to fully understand their needs and clearly communicate Pilot Line progress.

Quality / Regulatory Compliance:

  • Process control and pilot line operation according to controlled processes with clear recording of outputs and deviations.
  • Detail conscious and committed to achieving accuracy required.
  • Ensure full compliance with all relevant GMP and HSE requirements.

 

 

Requirements:

Essential:
  • Experience working in a manufacturing/engineering role, ideally including collaboration with R&D/process development, more ideally within GMP regulated industry e.g. medical devices.
  • Background in product/process engineering.
  • Proven people management skills.
  • Knowledge of statistical process controls, capabilities and analysis techniques.
  • Technical and team leadership skills.

 

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