Validation Engineer

Premier Engineering
Runcorn, UK
14 Jun 2019
19 Jun 2019
Contract Type
Full Time
Validation Engineer

£40,000 - £50,000


A global company, which is as a world leader in serving science is looking for a Validation Engineer. The company accelerates life science research, improves patient diagnosis, deliver medicines to the market and increases laboratory productivity. The Validation Engineer will lead the Engineering Change, Verification and Validation processes for all products. The Validation Engineer will be responsible for submitting change requests.

Responsibilities of the Validation Engineer
  • Own the end to end process for engineering change, verification and validation
  • Develop and implement robust verification and validation processes
  • Ensure consistency of approach, utilising risk, evidence and results-based protocols, trials and reports.
  • Provide technical authoring expertise and training to the team
  • Chair, or assign a team member to chair the change control meetings
  • Maintain efficacy of the Device Master Records and revision control
  • Control the approval and release of concessions, rework instructions, deviations.
  • Work cross-functionally to ensure actions are deadlines are complete. Assist with the identification and implementation of regulatory requirements, thus sustaining compliant, saleable products:

- Regulations, including IEC61010, REACH, RoHS, UDI

- Part obsolescence, Last time buy

- UL and EMC testing

Requirements of the Validation Engineer:
  • Strong background in engineering change or compliance
  • Degree or HND in an Engineering or Science based subject.
  • Experience of a lead role within a multi-disciplined engineering team
  • Capable of fully understanding and implementing the regulatory standards relating to Medical Devices and IVD
  • Proven ability to make quick decisions and act decisively
  • Able to gain a solid understanding of systems: Dataflo (ERP) and Q-Pulse (QMS)
  • Attention to detail & drives a right first time" approach
  • Proven ability to build strong cross-functional relationships and influence others
  • Ability to lead effective meetings and drive to closure on action items
  • Outstanding written, verbal, presentation, and influencing skills
  • Ability to use Continuous improvement techniques, such as value stream maps & Kaizens to effect change
  • Experience of using DOE, Engineering studies and V&V as part of a robust change control process

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