Biologics Maintenance Engineer
Team Horizon
- Co Westmeath
- Contract
- Full-time
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- Excellent contracting rates on offer.
- Proactively ensuring that all EHS responsibilities are carried out according to regulations and procedures including Risk Assessments, RAMS and safety GEMBAs.
- Provide support to new equipment installations and product introductions.
- Maintaining the Maintenance Quality System by adherence to all relevant SOP’s, 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 both within the DS facility and in the Engineering Stores.
- Ensure the Maintenance Management System is maintained correctly.
- Utilising and maintaining IT systems as required, e.g. Computerized Calibration Systems and Computerized Maintenance Management Systems.
- Leading shift-handovers and reporting issues using a Tier-meeting approach.
- Provide support to Operations, Validation, Engineering and Quality where required.
- Associate Degree &/or certification in a mech, elec or related field is required.
- 3-5 years experience in an appropiate 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 knowledgeable of cGMP for process equipment, instrumentats 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.
- A team player with a can do, pro-active attitude and a passion for improvement.