Validation Engineer - Medical Devices
Accountable to: Technology Transfer Manager
Russell Taylor Group has a fantastic opportunity to work as a Validation Engineer for a UK leading Medical Device organisation. The role will entail being a part of the NPD validations team. The person will work closely with validation protocols, equipment installations and operation/ performance qualifications all with in an ISO13485 & 9001 environment. Also complete other duties as requested by technology transfer manager and the production director.
- Perform process validation for New Product Development projects.
- Conduct equipment installation, operation and performance qualifications.
- Review existing qualifications and validations.
- Input into validation master plan.
- Generate Standard Operating Procedures and documentation updates.
- Create validation protocols, execute validation studies, analyse validation data and write final reports.
- Resolve technical issues encountered during study execution.
- Conduct risk assessments and PFMEAs.
- Provide training for other members of the team.
- Any other duties as may be requested by the Technology Transfer Manager or Production Director.
- An engineering or technical degree.
- Relevant experience in validation and re-validation techniques
- Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
- Excellent written communication and report writing skills.
- Good organisation skills and attention to detail.
- A can do, customer-focused attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
- Working knowledge of ISO 13485