A new bio-pharmaceutical organisation into the Irish market is expanding their 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 their biologics arm and have also acquired a new facility in mainland Europe. This site is based 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.

The Position

• Manage, coordinate and guide CTU CQV execution based upon the validation plan.
• Ensure adherence to project schedule timelines.
• Serve as a subject-matter expert on CTU workstream, routes and circuit related activities.
• Author & review commissioning and qualification documents such as IOC/Q protocols, qualification validation protocols, summary reports risk assessments and deviations.
• Owns the closure of any open issues such as 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 CTU-related issues.
• Identify and implement CTU related improvements where feasible.
• Supports system handover to Manufacturing/QC/Warehouse.
• Demonstrates proficiency in communicating and collaborating with stakeholders and vendors
• Participates in internal and external audits when required
• Temporary shift work may be required as needed

The Person

• A minimum of 2-5 years' experience for CTU CQV engineer role or 5+ years' experience for senior CTU 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 CTUs.
• Possess in depth knowledge of hazards associated with CTUs
• Experience in troubleshooting and providing technical and engineering solutions for CTU-based operations and equipment in a biologics or similar processing environment.
• Good interpersonal skills coupled with demonstrated ability to effectively work with cross functional area.
• Ability to manage and facilitate vendor or 3rd party testing companies ability to present and successfully defend technical and scientific approaches in both written and verbal form.
• Eng or B.Sc in engineering or relevant science discipline is required.
• A qualification in project management would be advantageous.

The Benefits

• Competitive hourly rate on offer

To discover more about this opportunity, apply now or contact AnneMarie Kelly at HRM on +353 87 4672251 for a confidential discussion.