- 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 firstname.lastname@example.org
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
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