Job Opportunity for Biotech C&Q Expert
We are seeking an experienced Commissioning and Qualification Engineer to join our team in Cork, Ireland.
* This contract position is part of the Technical Compliance Team, supporting project commissioning and qualification activities.
* The role involves providing input into all aspects of C&Q from design to commissioning completion, ensuring cGMP compliance through system and equipment design.
Key Responsibilities:
* Develop and execute C&Q protocols, including URSs, SRSs, Plans, and Impact Assessments.
* Review and approve contractor documents, compile documentation for inclusion in protocols/reports, and prioritize C&Q activities according to site and project schedules.
* Collaborate with project engineering, construction, and site operations teams, as well as the Quality Department.
Requirements:
* Minimum 5+ years of experience in the Pharmaceutical (API) Industry, with a focus on commissioning and qualifying systems/equipment.
* Knowledge of Project Delivery Processes (PDP) and current Good Engineering Practices (GEP).
Desirable Skills:
* Experience with ABB Industrial IT control systems.
* Pharmaceutical facility instrumentation knowledge.
* Extensive experience in commissioning and qualification of production systems, utilities, and facilities.
* Technical Compliance team experience in a multinational corporate environment.