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.
- 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.
- 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.
- 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