Job Title: Validation Engineer
Salary: £24-26k plus company perks
Location: Gloucester
My client are a global leader in medical products assisting clinicians, physicians and hospitals in developing quality medical products for better patient outcomes.
Key purpose of role
Responsible for implementation of validation of production processes and procedures, leading validation improvements with project based activities, including new product introduction and operational designs to reduce waste, improve quality and safety, and reduce operating costs.
Manage KPIs and ensure validation actions are taken to maximise success.
Work on phases or sub-tasks of projects or entire projects of moderate complexity, with results impacting on project completion.
Work under general supervision, reviewed at project milestones and/or on completion by Management.
Responsibilities of the role
Leadership of validation of manufacturing/production processes
Work with internal stakeholders to support validation activities as necessary
Have a fundamental understanding of lean manufacturing principals
Support NC/CAPA process.
Develop appropriate KPIs / metrics, and propose actions plans for Validation implementation and upkeep
Support Project Management and Engineering in the delivery of project on time, and on cost
Any other duties considered commensurate with this level of post
Evaluate validation processes; applying knowledge of product design, fabrication and assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators
Monitoring and testing equipment
Analysing and documenting test results
Preparing compliance reports
Directing validation activities
Resolving testing problems
Making adjustments or improvements to equipment and processes
Creating/modifying databases to track validation activities
Interpreting customer requirements
Developing validation schedules
Conducting training and overseeing the work of validation technicians
Keeping up to date on industry standards and regulations
Qualifications and experience
Degree and / or equivalent experience in an engineering discipline
Experience in validation / production / manufacturing
Proven experience in leading and developing people and supporting facilities activities (desirable)
Establishing metrics / KPIs to drive production / manufacturing improvement (desirable)
Worked in international quality standards, preferably medical devices ISO 13485 (desirable)
Developing standard operation procedures and work instructions
Previous experience
Validation experience within injection moulding / medical / computer systems (desirable)
Previous experience within medical device industry (desirable)
Experience in injection moulded parts and associated tooling, machinery and assembly (desirable)
If you're interested, please click apply now to submit your CV for screening. For more information, please contact Harvey in the Life Sciences team
