Our client, a medical device company in Galway are currently looking to recruit a Senior Validation and Compliance Engineer for their site.
Duties & Responsibilities:
- Reporting to the Facilities Manager, the duties of the position will include but not limited to:
- Working with Facilities Engineers to design protocols to ensure that new and existing clean rooms are adequately maintained and tested in accordance with ISO13485, 21 CFR and corporate Quality standards to ensure compliance to all regulatory standards.
- Prepare and execute protocols for validation of new clean rooms, software and facility equipment executing the testing and completing the reports in conjunction with Facilities Engineers and external vendors as required.
- Liaising with manufacturing, engineering, micro and other site departments to ensure compliance during site and facility changes.
- Liaising with external vendors in relation to test details and test reports as required.
- Ensuring that all required testing is completed in a timely manner and reports approved to meet project timelines.
- Reviewing all applicable regulatory standards to ensure that requirements are reflected in internal documentation and implementing changes when standards are revised.
- Maintain and update Facilities procedures, protocols and reports on Agile.
- Supporting audits of the Facilities Function when performed by internal auditors or notified bodies.
- Complete root cause investigation and implement mitigation plans in response to CAPA?s and deviations for the Facilities function
- Provide governance and auditing of processes and procedures in the Facilities function to ensure compliance.
- Contribute and lead problem-solving of facility and validation related issues.
- A min of a Level 8 NFQ Science or Engineering Degree level is essential; further post graduate study in a related discipline would be of benefit.
- Excellent verbal and written communication skills are essential for this role; a good working knowledge of validation principles would be a significant advantage.
- A minimum of 5 years? experience, with at least 2 years? experience in the Medical Device industry
- Ability to multi task and deliver on multiple projects simultaneously
- Compliance & Integrity: Promotes and practices a culture of integrity, ethics and compliance with laws and policies. Champions implementation of compliance policies, training and monitoring programs. Expeditiously takes appropriate actions when problems occur.
- Executes: Takes accountability for and delivers consistent decisions, actions and results. Aligns team, allowing people to move quickly in a coordinated fashion.
- Clear Thinking: Translates complexity into simplicity and articulates clearly. Creates and communicates a clear strategy/plan and demonstrates good judgment.
- Inspires Others: Authentic and sets a vision that inspires performance and engages others. Has infectious enthusiasm, seeks and values different perspectives and ideas to foster an inclusive work environment.
- Driven to Win: Passionate and driven, makes tough decisions in difficult situations. Results-oriented with the ability to rapidly prioritise and effectively determine the best course of action.
For further information on this Senior Validation and Compliance Engineer role in Galway please contact Deirdre Finnerty on 091730022 / email@example.com
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