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.
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of company Validation Policies and Procedures are addressed.
- Managing Complexity/Technical Accountability.
- Serves as technical expert for the Validation process and responsibilities to ensure compliance.
- Resolves & manages technical operational problems in area of expertise.
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process.
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness.
- Influences and persuades so as to bring about technical and process improvements.
- To ensure accuracy and maintenance of the company Validation Master List.
- To review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
- To ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
- 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.
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 45560 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 45560
- Posted: 17th May 2019
- Expires: 14th June 2019