VALIDATION ENGINEER - OFFALY
Validation Engineer - Offaly.
This is a contract posting of 6 months' duration.
This position will assist in managing & executing Validation projects and requires experience in:
• Equipment & Process Validation
• Facility & Utility Validation
• Method Validation
• Computer Systems Validation
RESPONSIBILITIES WILL INCLUDE:
• Review, preparation & approval of SOPs, qualification protocols, deviations and change controls
• Execution of validation protocols for equipment and processes.
• Management & Co-ordination of validation activities with internal departments, external contractors & suppliers.
• Preparation, review & approval of risk assessments for facilities, 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.
EDUCATIONAL REQUIREMENTS & RELEVANT EXPERIENCE:
• A Bachelor’s Degree in Engineering, Science or a related discipline required.
• Minimum of 3 years' validation experience in a similar role within a high volume manufacturing, regulated environment.
• Candidates from a Medical Device background will have a distinct advantage.
• 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.
• National & International travel is approx 10% of role.