Website Asset Recruitment
Commissioning & Qualification Lead – Utilities
The Commissioning & Qualification Lead – Utilities will be responsible for the management of the Commissioning and Qualification activities in our client’s facility new Drug Product Manufacturing plant in Carlow.
The role is a Site-based position, with initial 12 Month contract as part of the C&Q team.
• Lead a C&Q Team with key focus on:
> Co-ordination of combined C&Q Team (Vendor, Craft Contractor, Operations, Automation and C&Q Personnel)
> Review and approve C&Q test documentation for black & clean utility systems.
> Management of Weekly Activity Planning
> Mitigation of open issues (Punch Items, Non-Conformances etc)
> Assess and problem solve any deviations/ events effectively.
• To commission Utility systems with DeltaV & OEM automation.
• Provide compliance and technical review of testing protocols and reports.
• Possess a deep technical understanding of Clean and Black Utility unit operations
• Ensure all the Company standards and Local engineering regulations are followed for packages.
• Design and implementation of all commissioning activities according to site safety procedures.
• Support in the implementation of a Utilities Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
• Oversee vendor efforts for installation / testing of utility systems through OQ completion and start up.
• Troubleshooting for technical issues and escalating risks to the Process Lead and Suite Team Lead.
• B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or related.
• 6+ years Commissioning & Qualification experience in a Biologic Manufacturing Facility.
• Project Management and Problem-solving skills.
• Expertise in Qualification of equipment, including:
> Utility Generation
> Wastewater systems.