Job Title: Validation Engineer
Salary: £24-26k plus company perks
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
- 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.