A new bio-pharmaceutical organisation in the Irish market is expanding its global manufacturing operations network with a state-of-the-art campus. This site is the company's first venture into the Irish market and will support customer delivery across European markets. At present, the business employs over 3,000 staff globally within its biologics arm and have also acquired a new facility in mainland Europe. This site is based in North Leinster.
As a leading biologic services provider, the business offers comprehensive, integrated and customised services to over 200 clients globally including 13 of the top 20 biopharmaceutical company's worldwide.
As a key member of the site CQV project team, you will be involved in leading and supporting all aspects of downstream commissioning and validation for the site. This is a challenging position and will require flexibility and creative problem solving.
- 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.
- Be involved with the detailed design of validation solutions for the site around equipment implementation and networking.
- Be a go-to expert on Chromatography, Packing skids and columns, and Downstream related activities.
- Support FAT's and complete SAT's, IQ and OQ Protocols.
- You will support the resolution of deviations; running investigations across equipment and process deviations, system failures and under-performance ensuring root cause analysis are carried out, a solution is delivered, and corrective actions are implemented across systems and equipment.
- All applications must have a Degree in Engineering with a minimum of 5 years' experience within a project-based environment.
- The right person will have experience within a highly regulated GMP manufacturing operation - Pharmaceutical or Bio-tech.
- A strong portfolio of CQV work is required and proven skill in this area.
- Flexible approach to work and a positive attitude will be a good fit with the team dynamic
- Be collaborative in your approach to work and be an effective communicator.
- Autonomous with ability to work on your own initiative.
- Competitive hourly rate on offer
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.