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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senior Validation Engineer


Reference:SMC4566 Location: Limerick
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance
  • Continuous Learning/Managing Risk 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.
  • Facilitates successful team behaviour within Quality Systems and across functional areas Manages relationships externally and internally.
  • Builds cross functional and cross-departmental support, fostering overall effectiveness
  • Fosters harmony within Quality Systems.
  • Ensure accuracy and maintenance of the Validation Master List.
  • Review and approve Validation Master Plans, Protocols, Summary
  • Reports and other documentation associated with validations, as appropriate for each validation exercise.
  • Ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
  • Ensure that all validation activities are carried out and reported in a timely manner.
  • Ensure compliance through assisting in audits.

Experience & Education

-A degree level or similar qualification in mechanical or industrial engineering.
-Minimum 2 years experience in a quality role within a regulated industry.
-Proven knowledge and ability regarding product verification and process validations.
-Proven knowledge of FDA and MDD GMP requirements regarding medical devices.