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
- Liaise with CMT in relation to installation readiness and a schedule for QC equipment such as analytical instrument, QC autoclaves, BSC, Pass Box.
- Lead CQV review for Vendor Packages.
- Ensure Commissioning readiness to support QC instrument equipment testing.
- Lead PSSR field execution and guide equipment vendor in a safe and controlled manner.
- Develop wraparound qualification protocols/validation reports and execute all C&Q activities with equipment vendor.
- Assist the CQV PM in the planning and tracking of activities to ensure adherence to project schedule timelines.
- Facilitate QC instrument and equipment Turn over in conjunction with the site Operation Team (QC user team).
- Minimum of 3 years of C&Q experience.
- 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.
- Proven success working well in a team environment with flexibility to react to changing business needs.