Cqv Lead Engineer

CQV Lead Engineer - North of Ireland - 12 Months Contract

Do you want to be part of one of the top 10 best companies to work for in Ireland?

We have a superb opportunity for a Manufacturing Biotech Associate to join our client, a global pharmaceutical organisation in their new multifunctional facility.

Essential Duties and Responsibilities for this role include, but are not limited to, the following :

Work within a team of Validation professionals from 'Intern' level to Associate Director to own and execute the Validation & PQ aspects of the project.

Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.

Act as SME on the process & equipment within the assigned area.

Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.

Implementing the requirements as outlined in the site & project Validation Master Plan(s).

Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.

Authoring and reviewing standard operating procedures and technical reports including PQ protocols.

Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and / or validation counterparts.

Supporting regulatory submissions as required.

Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.

Effective application of LeanSixSigma and Change Management tools in the Validation group by leading by example in achieving results by using industry standard tools and processes.

Desirable Experience :

Extensive C&Q / QA / QC / Validation experience in highly regulated industry.

Experience in process equipment C&Q / QA / Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.

Presenting of QA / QC / Validation documents to regulatory agencies / inspectors and defending approach.

SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection.

Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.

Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.

If this role is of interest to you, please apply now!

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Engineering and Information Technology

Industries

Staffing and Recruiting

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