Description
Biologics Maintenance Engineer
Team Horizon is seeking a Biologics Maintenance Engineer for a leading pharmaceutical company based in Athlone.
The Biologics Maintenance Engineer is responsible for the managing the routine and non-routine maintenance activities carried out by the maintenance technicians. This includes all Upstream and Downstream production equipment and systems. This position is also responsible for the planning, co-ordination and scheduling of maintenance works performed by service vendors in a DS environment. The individual in this position is expected to represent the company interests, objectives and policies in a professional and responsible manner. This role will report into the Biologics Engineering Manager in the area and will offer scope for both personal and career development.
Why you should apply:
• 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.
What you will be doing:
• 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.
What you need to apply:
• 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.