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Downstream CQV Engineer
This role will support the commissioning & qualification activities for a number of Downstream Ultrafiltration/Diafiltration (UF/DF) and Bulk Filling Skids used on the cGMP manufacture of biological bulk drug substance (BDS). 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 Downstream 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, 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.
• Leads and maintains a safe working environment during CQV e.g. Work Permits, Safe Plans of Action, COHE, LOTO, etc.
• 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 communicating and collaborating with stakeholders and vendors
• Participates in internal and external audits when required
• Temporary shift work may be required as needed
• B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
• 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).
• Possess in-depth knowledge of UF/DF and Bulk Filling Skid operation & Downstream processing in Biopharma.
• 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 demonstrated ability to effectively work with cross functional area.
• Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
Desirable but not essential:
• Experience of UF/DF and Bulk Filling Skid operations for a multiproduct facility is advantageous.
• A qualification in project management