Utilities Validation/Verification Engine

CPL

Dublin West

Summary. The role of the Utility Validation Engineer is to work with the Validation lead as part of a team that is responsible for commissioning of utilities such as instrument air, water systems, plant steam and qualification on Utilities such as Water for Injection (WFI), Reverse Osmosis (RO), Purified Water (PW), clean steam, clean gases, HVAC, and other equipment such as Freezers, Cold rooms, parts washers, autoclaves and isolators. The role will involve managing and completion of commissioning and qualification of utilities and equipment for projects. The role will also involve identification and execution of process improvements. Responsibilities: Working as part of a team to manage and execute commissioning and qualification of new/modified utilities and equipment. Write, review and approve commissioning, verification, qualification and revalidation test documents, plans and reports to site procedures, and to GMP and regulatory standards. Ensuring systems operate and are tested to regulatory and international standards. Ensuring systems meet acceptance criteria and that the systems are robust. Interface with selected equipment vendors, design and project management engineering groups and system owners to clarify scope, generate costs, review design, and complete commissioning and qualification of utilities and equipment, as required. Complete system walk-downs and acceptance from Construction including verifying drawings and documentation meet site standards and that relevant construction and installation testing has been satisfactory completed. Set up and review of instruments and equipment on the site maintenance system to ensure calibrations and maintenance meet regulatory, equipment and process requirements. Test functionality of new or modified utilities and equipment. Experience. Experience commissioning, qualifying and/or verifying GMP utilities and HVAC. Experience writing, reviewing and/or approving commissioning, verification, qualification and/or revalidation test documents, plans and reports. Experience working in a GMP environment. Knowledge of utility regulatory requirements and testing acceptance criteria. Following would be an advantage. Experience with working in a Biotech facility. Experience managing commissioning and qualification for projects and/or revalidation. Experience on process improvements. Qualification / Requirements. Education: Qualified Engineer, Science graduate or equivalent experience. Contract Lenght: 12 Months. If you would like to discuss this role in confidence, please email me on; eamonn.errity@cpl.ie or, by phone; 01 614 6069. This job originally appeared on RecruitIreland.com.

2382 days ago