Commissioning & Qualification Lead / Ireland

Currently recruiting a Commissioning & Qualification Lead on behalf of our Multinational Biotechnology Client based in South Dublin on initial 12-Month contract with huge potential to extend.

Lead a team of C&Q engineers to ensure the C&Q activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

* Coordinates and Supervises all C&Q activities

* Approves C&Q planning documents detailing overall strategy for the project.

* Develops and approves the master list of C&Q test documents and activities.

* Reviews and Approves all C&Q summary reports.

* Ensures the C&Q schedule is developed and maintained.

* Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.

* Pre-Approval and Post approval of C&Q test documents.

* Manages Daily C&Q coordination meetings.

* Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.

* Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.

* Management and tracking of turnover process data base, including Walkdowns, Turnover Packages, Mechanical Completion, Final Completion.

* Day to day liaison with the Construction Management Team

* Generation of the Turnover and Care, Custody Control strategy and plan for the project (including use of project databases)

* Management, collation and presentation of Right First Time data for protocol and turnover package review

* Writing of test protocols when required

* Compilation and Presentation of weekly progress summaries for project

* Review and approval of vendor equipment turn over packs and test documentation.

* Use of the Risk-based ASTM E2500 standards and approach to Qualification

* Liaise with C&Q Engineers and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place

* Ensure Commissioning readiness of all Systems to support Equipment Start-up and C&Q Testing

* Liaise with all Project Groups (Design/CM/C&Q/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure Systems are managed appropriately for the entire Project Lifecycle

Qualifications & Requirements:

* Minimum 10 years C&Q experience

* Working knowledge of ASTM E2500 / Leveraging Verification process

* Minimum of 10 years experience with design and construction projects for biopharmaceutical manufacturing facilities

* Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Office / Project)