C&Q Lead

  • Contract
  • Dublin

Website TPM05407

Summary:
Our client is a biopharmaceutical company based in South Dublin looking for a Commissioning and Qualification (C&Q) Lead for a largescale 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.

Qualifications & 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).

To apply for this job email your details to Orla.daly@tandempm.ie.