Commissioning & Qualification (C&Q) Lead

at  Team Horizon

Commissioning & Qualification Lead
Team Horizon is seeking a Commissioning & Qualification Lead for a leading pharmaceutical company in South Dublin. Lead a team of C&Q engineers to ensure the C&Q activities associated with a large equipment project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• 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.

What you need to apply:

• 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).

• 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