CQV Engineer
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| Job Type | Contractor |
| Location | Louth |
| Area | Louth, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002072 |
| Job Views | 141 |
- Description
- Senior CQV Engineer – Team Horizon
Our client has an exciting new opportunity. If successful, your role will be to support the commissioning & qualification activities of a large number of stainless-steel skids for the cGMP manufacture of biological bulk drug substance (BDS) at a biologic’s facility in Louth. You 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.
Why you should apply:
You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
They put their people first and live their diversity and inclusion values embracing all
perspectives.
You enjoy working in a culture of learning and collaboration and making a positive impact.
What you will be doing:
Manage CQV execution based upon the site validation plan.
Accomplish timely delivery of the project.
Act as a subject-matter expert (SME) on stainless steel equipment and related activities.
Write and review commissioning and qualification documents
Owns the closure of any open issues such as FAT/SAT punches & deviations.
Closely manages compliance issues as they arise.
Adheres to safety regulations during CQV e.g., Safe Plans of Action, COHE, LOTO, etc.
Trouble shoot process and equipment-related issues.
Classify and implement improvements where feasible.
Assists system handover to Manufacturing.
Participates in internal and external audits when required
Temporary shift work may be required as needed
What you need to apply:
Bachelors of Science in Engineering Chemical / Process engineering or relevant science discipline is required.
A qualification in project management is desirable.
3+ years’ experience for a CQV engineer role working in a Biologics or similar GMP environment as part of an engineering or technical services function.
Experience with facility start-up projects.
Proficiency in communicating and collaborating with stakeholders and vendors
Skilled at the execution of commissioning and qualification of stainless-steel vessels, and associated pipe-work.
Expert of buffer and media operations & processing in Biopharma.
Experience is commissioning and qualification of CIP skids would be a distinct advantage.
Extensive knowledge of CIP in a biopharmaceutical or similar environment would be a distinct advantage
Knowledge and experience in operating Delta V driven systems.
Knowledgeable regarding start up hazards associated with start up
Solution focussed and experience in troubleshooting
Skilled at in automation change control.
Great interpersonal and collaborative skills
Brilliant presentation skills
Excellent communication skills
Team leadership skills would be a distinct advantage
Knowledge of Buffer and Media operations within a multiproduct facility is advantageous
Widespread knowledge of CIP in a pharmaceutical or similar environment would be a distinct advantage