Commissoning and Qualiification lead

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.

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)