Downstream CQV Engineer 1194
SimoTech are looking for a Downstream CQV Engineer for a project in Leinster. This role will support the commissioning & qualification activities for several downstream chromatography & packing skids and columns used for the manufacture of biological bulk drug substance (BDS) on a key client site.
- Manage, coordinate, and guide the CQV of chromatography, packing skids and columns 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.
- Own 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.
- B.Eng. or B.Sc. in Chemical / Process engineering or relevant science discipline is required.
- Experience operating in a DeltaV environment would be a distinct advantage.
- A minimum of 3 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.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.