A new bio-pharmaceutical organisation in the Irish market is expanding their global manufacturing operations network with a state-of-the-art campus in North Leinster. 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 their biologics arm and have also acquired a new facility in mainland Europe. This project role is on an initial short-term contract with about 2 years of work left to complete.
This role will support the commissioning & qualification activities for a number of Downstream Ultrafiltration/Daifiltration (UF/DF) and Bulk Filling Skids. The Downstream CQV Engineer will also provide expertise to support the start-up into routine commercial manufacturing. The position is accountable for the timely completion of all Dowmstream UF/DF & Bulk fill skid-related commissioning and qualification milestones.
Manage, coordinate and guide UF/DF and Bulk Filling Skid CQV execution based upon the validation plan.
Ensure adherence to project schedule timelines.
Serve as a subject-matter expert on UF/DF and Bulk Filling Skid, and associated Downstream related activities.
Author & review commissioning and qualification documents such as IOQ protocols, qualification validation protocols, summary reports risk assessments and deviations.
Owns the closure of any open issues such as FAT punches & deviations.
Proactively recognises and highlights any compliance issues as they arise.
Trouble shoot Downstream process and UF/DF and Bulk Filling Skid related issues.
Identify and implement UF/DF and Bulk Filling Skid related improvements where feasible.
Supports system handover to Manufacturing.
Demonstrates proficiency in communciating and collaborating with stakeholders and vendors.
Participates in internal and external audits when required.
A minimum of 2-5 years' experience for Downstream CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.
Experience operating in a Delta V environment.
Knowledge and experience with facility start-up projects (brown field or green field).
Experienced in the execution of commissioning and qualification of UF/DF and Bulk Filling Skid and associated process equipment (e.g. filtration systems, Single Use Bag Holders, etc).
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 752 1041 for a confidential discussion.