Biologics Maintenance Engineer
We are seeking a Biologics Maintenance Engineer to join our team at Horizon, a leading pharmaceutical company based in Athlone.
The ideal candidate will be responsible for managing routine and non-routine maintenance activities carried out by maintenance technicians, including Upstream and Downstream production equipment and systems.
This role will involve planning, coordinating, and scheduling maintenance works performed by service vendors in a DS environment. The individual will also represent the company's interests, objectives, and policies in a professional and responsible manner.
This is an exciting opportunity to join a world-class manufacturing operation with a strong track record of delivering high-quality medicines to patients worldwide.
You will work closely with our experienced team to ensure that all EHS responsibilities are carried out according to regulations and procedures. This includes providing support to new equipment installations and product introductions.
Responsibilities:
* Proactively ensuring that all EHS responsibilities are carried out according to regulations and procedures.
* Providing support to new equipment installations and product introductions.
* Maintaining the Maintenance Quality System by adherence to all relevant SOPs, policies, and cGMP requirements.
* Plan and coordinate scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
* Maintaining spare parts, change parts, and equipment within the DS facility and in the Engineering Stores.
* Ensure the Maintenance Management System is maintained correctly.
Requirements:
* Associate Degree &/or certification in a mech, elec or related field is required.
* 3-5 years 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 Computerized Calibration Systems.
* Prior experience with Quality Management Systems. 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.
* Ability to make informed and timely decisions that take into account the facts, goals, constraints, and risks associated.
Our Company:
Horizon is a leading pharmaceutical company committed to delivering innovative solutions to improve patient outcomes. We strive to create a positive and inclusive work environment that fosters collaboration, growth, and development.