Website Asset Recruitment
Downstream CQV Engineer
This role will support the commissioning and qualification activities for Downstream Chromatography, Packing skids and columns 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 chromatography-related commissioning and qualification milestones.
• Manage, coordinate and guide Chromatography, Packing skids and columns CQV execution based upon the validation plan.
• Ensure adherence to project schedule timelines.
• Serve as a subject-matter expert on Chromatography, Packing skids and columns, and 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 Upstream process and Chromatography, Packing skids and columns related issues.
• Identify and implement Chromatography, Packing skids and columns 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
• Bachelor’s degree in Chemical / Process engineering or relevant science discipline
• 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.
• Knowledge and experience with facility start-up projects (brown field or green field).
• Experienced in the execution of commissioning and qualification of Chromatography, Packing skids and columns and associated process equipment (e.g. filtration systems, Single Use Bag Holders, etc).
• Possess in-depth knowledge of Chromatography, Packing skids and columns operation & Downstream processing in Biopharma.
• Possess in depth knowledge of hazards associated with Chromatography, Packing skids and columns start up
• Experience in troubleshooting and providing technical and engineering solutions for Chromatography, Packing skids and columns-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.
• Experience of Chromatography, Packing skids and columns operations for a multiproduct facility is advantageous.
• Experience operating in a Delta V environment would be a distinct advantage.
• A qualification in project management would be advantageous.