An exciting new 12 month contract has become available for a Validation contract Engineer in a market leading medical device company. Candidate's responsibilities will be to manage and support assigned projects through validation to completion and will receive general guidance from functional management.
Validation Engineer Responsibilities will be
- Provide technical support within the validation life-cycle including new equipment introduction, process improvement programmes, and engineering changes to include documentation
- Generation and independent review of validation lifecycle deliverables and documentation as required to ensure compliance with regulatory authorities and fitness for purpose of business systems and equipment (this may require execution of protocols)
- Providing support for the control of non-conforming product/systems and CAPA to ensure compliance and continuous improvement of the business
- Provide support for risk management activities to ensure compliance and continuous improvement of the business
- Ensure compliance with ISO 13485:2003, FDA 21 CFR Part 820 and other International Regulatory requirements.
- This role reports to a Senior Manufacturing Engineer and provides validation expertise and plays a lead role in driving equipment and process validation improvement initiatives.
Validation Engineer Requirements;
- Understanding of and experience in the following subsections; DQ, CQ, IQ,OQ,PQ
- Validation expereince within a Medical Device company is a must
- Technical writing expereince
- Use of statistical techniques for data analysis
- Ability to follow project management plans
- Continuous improvement experience (6-Sigma / Lean / TMP)
Should you wish to apply for this position then please feel free to contact me as on or contact me on 0207 758 7322.
Keywords: Validation Engineer, Validate, Validation, Quality Systems, Technical Writing, ISO 13485:2003, FDA 21 CFR Part 820, DQ, CQ, IQ,OQ,PQ,
To find out more about Real please visit www.realstaffing.com