Our client, a packaging company in Offaly are currently looking to recruit a Validation Engineer for their site.
The successful candidate will assist in managing & executing Validation projects and requires experience in:
- Equipment & Process Validation
- Machine Related Software Validation
- Method Validation
- Computer Systems Validation
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.
Educational Requirements & Relevant Experience:
- 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.
- Computer literate
- Self-directed and results driven team player with excellent communication skills.
For further information on this Validation Engineer role in Offaly please contact Anna McGowan on 091730022 / firstname.lastname@example.org
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