Website Asset Recruitment
Senior CQV Role – Stainless Steel Vessels & Associated Pipe Work
This role is to support the commissioning & qualification activities of a large number stainless steel skids (including vessels (fixed and mobile) & associated pipework) for the cGMP manufacture of biological bulk drug substance (BDS) at a leading Biopharma facility in Louth. The Senior CQV Engineer will also provide expertise to support the start-up into routine commercial manufacturing. The position is accountable for the timely completion of the stainless steel-related commissioning and qualification milestones.
Essential Duties and Responsibilities
• 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
• A minimum of 3-5 years’ 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.
• Although not essential, experience is commsionong and qualification of CIP skids would be a distanct advantage.
• Possessing in depth knowledge of CIP in a biopharmaceutical or similar environment would be a distinct advantage
• 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, media and CIP-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.
The following experience would be strongly advantageous:
• Experience in leading a team of CQV engineers to deliver the qualification of process equipment would be a distinct advantage
• Experience of Buffer and Media operations within a multiproduct facility is advantageous
• Possessing in depth knowledge of CIP in a pharmaceutical or similar environment would be a distinct advantage
• B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
• A qualification in project management would be advantageous.