CQV Lead Engineer - North of Ireland - 12 Months ContractDo 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 Associates 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! #LI-DH1