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 CQV Engineer with specialisation in Filling Line equipment. This site will manufacture for global supply and is expanding as a response to growing customer requirements.

If you are passionate about science, enjoy the challenge of working in a start-up environment and are ambitious this is a fantastic opportunity to join a rapidly expanding organisation.

The Position

As a key member of the site CQV team you will be involved in leading and supporting various aspects of commissioning, qualification and validation as the site moves into C&Q phase. Responsibilities will include:

• Working on a team of experienced professionals; engineers and senior specialists across the site. You will work closely within this group and liaise with on-site teams to support the operational readiness plan from a CQV perspective.
• Manage approvals for CQV Documentation relating to Filling Line equipment (this may include vial washers, sterilisation tunnels, the filling line itself, stoppers, cappers, freeze dryer machines etc),
• Oversee generating approvals and the management of GMP documentation.
• Track and review all executed copies before submission to QA Dept.
• Support with deviation resolutions across the CQV network.
• You will work closely within this group and liaise with multi-disciplinary teams on-site to deliver effectively against the business' objectives.
• Assist with investigations of equipment and systems as required.

The Person

You will have skills and experience in the following areas to be considered:

• All applications must have a Degree in Engineering, Science or similar with a minimum of 4 years' experience within a GMP manufacturing environment.
• Previous experience working with filling line equipment.
• A strong communicator with the ability to work well within a cross-functional team to achieve a common objective.
• Collaborative approach to work and a positive attitude will be a good fit with this team dynamic.
• Thorough knowledge of safety, GMP and environmental regulatory requirements around site utilities systems

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.