C&Q Engineer - Clean Utilities

KPC International - Excellence from Concept to CompletionC&Q Engineer - Clean Utilities

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.

This person will be responsible for all Commissioning and Qualification of utility systems, gasses, chillers, WFI, clean steam in a pharmaceutical environment.

Job details:

• 12 month contract with possibility of extension based in Ireland, Co. Kerry
• On site role
• Immediate start

Main duties will include:

• Commission and qualify pharmaceutical utility systems.
• Develop and execute commissioning protocols, IQ/OQ/PQ documentation, and test scripts for utility systems.
• Perform field inspections, system walkdowns, and verification of installation against design drawings and specifications.
• Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all equipment and utilities are tested in compliance with project-related standards from a commissioning perspective.
• Deviation management associated with the assigned equipment and utilities.
• Collaborate with Engineering, Validation, QA, and Operations to ensure seamless integration of utilities into GMP operations.
• Support risk assessments, impact analyses, and change control processes for utility systems.
• Execution of FAT testing and leveraging results into the overall qualification process for assigned equipment, facilities and utilities.

Experience Required:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• 6 - 10 years of experience in Clean Utilities Commissioning, Qualification, and Validation in a pharmaceutical or biotechnology setting.
• Demonstratable capacity to effectively execute the CQ testing approach assigned from initiation to completion.
• Experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems, as well as Clean Steam and High Purity Gas Systems.
• In-depth knowledge of regulatory requirements, including cGMP, FDA, and other relevant standards.
• Strong project management skills and ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
• Proven ability to work independently and make informed decisions to support clean utility operations.

KPC-International is an Equal Opportunity Employer who offer an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.

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