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This role will support the commissioning & qualification activities for a number of Downstream Ultrafiltration/Daifiltration (UF/DF) and Bulk Filling Skids used in cGMP manufacture of biological bulk drug substance (BDS) at our clients advanced technology facility in Louth.
The Downstream CQV Engineer will also provide expertise to support the start-up into routine commercial manufacturing. The position is accountable for timely completion of all Downstream UF/DF & Bulk fill skid-related commissioning and qualification milestones.
• Serve as a SME on UF/DF and Bulk Filling Skid and associated Downstream related activities.
• Manage and coordinate UF/DF and Bulk Filling Skid CQV execution based upon the validation plan.
• Ensure adherence to project schedule timelines.
• Trouble shoot Downstream process and UF/DF and Bulk Filling Skid related issues.
• 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.
• Leads and maintains a safe working environment during CQV e.g. Work Permits, Safe Plans of Action, COHE, LOTO, etc.
• Identify and implement UF/DF and Bulk Filling Skid related improvements where feasible.
• Supports system handover to Manufacturing.
• 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
• 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.
• Possess in-depth knowledge of UF/DF and Bulk Filling Skid operation & Downstream processing in Biopharma.
• 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 ( filtration systems, Single Use Bag Holders, etc).
• Possess in depth knowledge of hazards associated with UF/DF and Bulk Filling Skid start up
• Experience in troubleshooting and providing technical and engineering solutions for UF/DF and Bulk Filling Skid -based operations and equipment in a biologics or similar processing environment.
• Experience in automation change control.
• Good interpersonal skills coupled with ability to effectively work with cross functional area.
• Ability to present and defend technical and scientific approaches in both written and verbal form.
• Experience of UF/DF and Bulk Filling Skid operations for a multiproduct facility is advantageous.
• B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
• A qualification in project management would be advantageous.