NRL are recruiting for a C&Q Engineer on behalf of our Irish client, to work on a large number of stainless steel skids, based in Dublin.
Duties & 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 communicating and collaborating with stakeholders and vendors
Participates in internal and external audits when required
Temporary shift work may be required as needed
Requirements:
Experience for a 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 commissioning and qualification of CIP skids would be a distinct 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.
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.
What’s in it for you:
Competitive hourly rates
Stable contract duration