Hobson Prior are looking for a Validation Engineer to join a medical device company who focus on innovative medical devices and solutions in orthopaedics, spinal care and neuroscience.
- Conduct validation activities in compliance with US and EU relations, GBSC procedures and EHS requirements.
- Contribute in the design of systems and equipment to ensure that they comply with GMP requirements.
- Develop validation documentation as required.
- Develop pFMEA documentation to support processes as part of Validation process.
- Review and approve documents prepared by the validation team, other departments and contractor organisations.
- Perform qualification protocols as required.
- Gather relevant documentation from contractors, suppliers and other departments for inclusion in reports.
- Generation/Modification of Process Specifications as required Prepare and execute validation protocols/reports.
- Initiate and implement change control activities in accordance with site procedures.
- Develop validation plans for site and projects as part of validation planning or re-validation activities as appropriate.
- Track and resolve exceptions during qualification activities.
- Organise qualification activities with engineering, construction and commissioning activities.
- Manage qualification activities with contractors and vendors as required.
- Organise qualification document review and approval.
- Gather and organise qualification files for turnover to QA DC/ route of PLM.
- Knowledge of bespoke validation. Process knowledge and documentation.
- In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry would be desirable.
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations is admirable.
- Working experience of validation computer systems for use in a FDA regulated environment is admirable.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.