Commissioning and Qualification Lead

PE Global are currently recruiting for a Commissioning and Qualification (C&Q) Lead, for a client site in Dublin 

12 month initial contract, with a view to extending.

Commissioning and Qualification (C&Q) Lead for a large scale Fill Finish Project in the Pharmaceutical Industry.

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.

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

Knowledge and Experience:

• 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)

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up to date CV to chloe.slingsby@peglobal.net