Commissioning Engineer

Headcount Solutions Limited • Dublin, City of Dublin • Posted January 24, 2025

Position Overview

Commissioning Engineer The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects. Key Responsibilities: * Develop and execute commissioning plans for new and existing equipment and systems.

* Perform equipment start-up and troubleshooting to ensure proper operation. * Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems. * Analyze qualification data and prepare comprehensive reports.

* Develop and execute validation protocols for processes and computer systems. * Conduct risk assessments and gap analyses to identify critical process parameters and control strategies. * Prepare and maintain detailed documentation, including protoc...