Validation Engineer - Leeds
CK Group is recruiting for a Validation Engineer to join a company in the pharmaceutical industry at their site based in Leeds on a contract basis for 6 months initially.
Our client is a multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company who offer the worlds most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
The role is based at our client's state of the art R&D and production facility in Leeds. This site is a short distance from the M621 and is easily commutable on public transport as it is a short distance from Leeds city centre.
- Continuous Improvement Focus
- Conduct validation activities in compliance with US and EU relations, GBSC procedures and EHS requirements
- Participate 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
- Execute qualification protocols as required
- Compile 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
- Coordinate qualification activities with engineering, construction and commissioning activities
- Coordinate qualification activities with contractors and vendors as required
- Coordinate qualification document review and approval
- Collate and organise qualification files for turnover to QA DC/ route of PLM
- In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
- Must be able to lead and give direction to Validation Projects and Teams.
- The individual must also be an active team member in Validation activities.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457725 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46108 in all correspondence.