Validation Engineer with 2-3 years experience required for permanent role in the midlands. The successful candidate will be responsible the management & co-ordination of Validation activities (software/ equipment/ process) with internal departments, external contractors & suppliers.

Key Responsibilities:

  • Review, preparation & approval of SOPs, qualification protocols, deviations and change controls.
  • Execution of validation protocols for equipment and processes.
  • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
  • Provide related updates to department management according to the latest EU/U.S and ICH requirements.
  • Review validation documentation from contract vendors to ensure that company requirements are met.
  • Initiate and implement change control activities in accordance with site procedures.
  • Providing Validation expertise to all areas of the facility.
  • Conduct training in Validation methodologies and related procedures as required.
  • Present validation systems at internal and external audits and support quality assurance programmes.
  • Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.

 

Requirements: 

  • Degree in Engineering, Science or a related discipline required, and/or significant experience in a similar role in a medical device/packaging environment.
  • 2/3 years’ experience in validations required
  • Strong statistical skills and process capability are required.
  • Strong report writing skills
  • Self directed and results driven team player with excellent communication skills.

 

Desirable:

  • Lean/Six Sigma Training an advantage.
  • Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions.
  • Proficient at multitasking and prioritizing.
  • Candidates from a Medical Device background will have a distinct advantage.
  • ISO 9001 and/or ISO 13485 knowledge.
  • Internal Auditor Training
  • Experience with Software validation desirable

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

IND1623

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