Leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for an experienced C&Q Engineer with specialisation in QC Instrument Equipment. This site will manufacture for global supply and is expanding in response to growing customer requirements.
If you are passionate about technology, enjoy the challenge of working in a start-up environment and are ambitious this is a fantastic opportunity to join a rapidly expanding organisation.
Reporting to CQV Lead as part of a multi-discipline team responsible for Commissioning and Qualification activities. Coordinate activities between Construction, Utilities, Automation, Operations
- Manage, coordinate and guide Autoclaves and Parts Washer CQV execution based upon the validation plan.
- Ensure adherence to project schedule timelines.
- Serve as a subject-matter expert on Autoclaves and Parts Washer related activities.
- Author & review commissioning and qualification documents such as IOQ protocols, qualification validation protocols, summary reports and deviations.
- Owns the closure of any open issues such as SAT punches & deviations.
- Proactively recognises and highlights any compliance issues as they arise.
- Leads and maintains a safe working environment during CQV e.g. Work Permits, Safe Plans of Action, LOTO, etc.
- Trouble shoot Autoclaves and Parts Washer related issues.
- Supports system handover to Manufacturing.
- Demonstrates proficiency in communicating and collaborating with stakeholders and vendors
- Minimum of 2-5 years of C&Q experience in process equipment validation.
- Knowledge and experience with facility start-up projects (brown field or green field).
- Experience with complex projects and working in or around operating facilities.
- Ability to keep work pace and meet deadlines.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
To discover more about this opportunity, apply now or contact Emma Mullen at HRM on +353 87 636 9263 for a confidential discussion.