Maintenance Engineer
This role offers the opportunity to support a leading pharmaceutical organisation in their mission to drive innovation. We are recruiting for a Maintenance Engineer to support our Dublin facility.
Located near Dublin Airport and just a short distance from the vibrant Irish capital, this organisation paves the way with state-of-the-art technology on their manufacturing facility.
Key Responsibilities:
* Proactively ensure all EHS responsibilities are carried out according to regulations and procedures including Risk Assessments, RAMS, and safety GEMBAs.
* Support new equipment installations and product introductions.
* Maintain the Maintenance Quality System by adherence to relevant SOP's, policies, and cGMP requirements.
* Plan and coordinate scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
* Maintain spare parts, change parts, and equipment within the DS facility and in the Engineering Stores.
* Ensure the Maintenance Management System is maintained correctly.
* Utilise and maintain IT systems as required, e.g., Computerised Calibration Systems and Computerised Maintenance Management Systems.
* Lead shift-handovers and report issues using a Tier-meeting approach.
* Provide support to Operations, Validation, Engineering, and Quality where required.
Requirements:
* An Associate Degree &/or certification in a mech, elec, or related field is required.
* 3-5 years of experience in an appropriate cGMP commercial manufacturing environment, preferably with experience on upstream (cell culture) and downstream purification.
* Prior hands-on experience with CMMS and Computerised Calibration Systems.
* Prior experience with Quality Management Systems.
* A high level of interpersonal, communication, and technical problem-solving skills.
* Demonstrable knowledge of cGMP for process equipment, instruments, and calibration. Knowledge of Six Sigma and lean systems is an advantage.
* The ability to make informed and timely decisions that take into account the facts, goals, constraints, and risks associated.