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VALIDATION SPECIALIST

Job Title: VALIDATION SPECIALIST
Contract Type: Permanent
Location: Leeds, West Yorkshire
Industry:
Salary: Negotiable
Reference: J894608_1521477570
Contact Name: James Lowe
Contact Email: James.Lowe@russell-taylor.co.uk
Job Published: March 19, 2018 16:39

Job Description

Validation Engineer - Medical Devices

Location: Leeds

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.

Responsibilities

  • 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.

Qualifications/Experience

  • 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

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