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 12-mth contract with about 2 years of work left to complete.
- Manage, coordinate and guide CQV execution based upon the site validation plan.
- Ensure adherence to project schedule timelines.
- Serve as a subject-matter expert on stainless steel equipment (buffer & media vessels together with associated pipework) and 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/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, COHE, LOTO, etc.
- Trouble shoot process and equipment-related issues.
- Identify and implement 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.
- Temporary shift work may be required as needed.
- Degree qualififed with a minimum of 3years' experience for CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.
- Knowledge and experience with facility start-up projects (brown field or green field).
- Experienced in the execution of commissioning and qualification of stainless steel vessels, and associated pipe-work.
- Possess in-depth knowledge of buffer and media operations & processing in Biopharma.
- Knowledge and experience in operating Delta V driven systems.
- Possess in depth knowledge of hazards associated with start up
- Experience in troubleshooting and providing technical and engineering solutions for buffer and media-based operations and equipment in a biologics or similar processing environment.
- Experience in automation change control.
- Good interpersonal skills coupled with demonstrated ability to effectively work with cross functional area.
- Competitive hourly rate on offer.
To discover more about this opportunity, apply now or contact Emma Mullen HRM on +353 87 6369263 for a confidential discussion.