Validation Engineer | Collins McNicholas

Validation Engineer

  • Reference: AJ40720x
  • Job Type: Permanent
  • Location: Laois, Offaly, Westmeath
  • Category: Medical Devices

We are currently recruiting a Validation Engineer to join the team who will assist in managing & executing Validation projects and requires experience in: 

  • Equipment & Process Validation- Mandatory
  • Machine Related Software Validation
  • Method Validation
  • Computer Systems Validation

 

Validation Engineer responsibilities:

  • Review, preparation & approval of SOPs, qualification protocols, deviations and change controls
  • Management & co-ordination of validation activities with internal departments, external contractors & suppliers.
  • Preparation, review & approval of risk assessments 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
  • 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.

 

 Validation Engineer will have/be:

  • A Degree in Engineering, Science or a related discipline required, and/or significant experience in a similar role and experience in a medical device environment.
  • Lean/Six Sigma Training an advantage
  • Strong statistical skills and process capability are required.
  • Available for National & International travel- approx 10% of role.

For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email tina.egan@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!

 


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Tina Egan

Contact Consultant

  • Tina Egan
  • Recruitment Consultant
  • 09064 50663
  • Connect with Tina

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