Junior industry position
Location Cork, IrelandApply BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Maintenance Engineer will be responsible for ensuring that all maintenance systems are implemented and operated in an efficient manner with a focus on continuous development. The Maintenance Engineer will ensure that equipment is maintained on site in a safe, compliant and efficient manner utilizing the current best in class maintenance/reliability strategies and methodologies.
The Maintenance Engineer will provide high levels of customer service to all departments including manufacturing, Quality control and Manufacturing Science laboratories in a Biologics Drug substance manufacturing facility. The maintenance technician is a key member of the Maintenance on call team ensuring equipment remains operational during normal hours and out of normal business hours. This position will report to Engineering and Reliability Manager with the Facilities Services Department.
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
The position of Maintenance Engineer is responsible for maintenance and facility related activities required to maintain a safe, quality compliant and highly reliable plant. While ensuring that manufacturing and laboratory operations have the services required to meet the needs of a fast paced, flexible Biotechnology facility.
Main areas of responsibility:
Implement the strategy for ensuring all plant equipment exists in the correct equipment status on CMMS, and that all equipment is assigned a relevant maintenance activity program according to equipment criticality ranking Development of the facility and maintenance site budget. Ensure all aspects of maintenance adherence to the facilities/maintenance budget throughout a financial year Co-ordinate and complete Quality records/actions to track progress and ensure compliance to cGMP’s, environmental and statuary regulations Manage and coordinate the alarm response strategy for daytime, evening and night time hours Develop a culture for optimizing Reliability and Maintenance systems for the business Manage the change process of maintenance program changes for all equipment to ensure that all changes are captured, documented, risk assessed and meet the applicable cGMP or statutory safety standards Develop a process to enable continuous improvement in all aspects of facility and maintenance related activities. Generate, report and analyze key maintenance metrics Ensure that all cGMP safety training is completed prior to engaging in any activities Ensure that all work is planned & permitted in line with the site safety management system Ensure that all contractors working on the site are competent, suitably inducted, documented and contracted prior to the execution of their activities Set up and control of site maintenance service contracts Responsible for controlling site repairs and maintenance activities
Projects: Provide support to the project team in the areas of:
Co-ordination of upload of new equipment to CMMS in accordance with existing site conventions and hierarchies Identification of critical spares for new equipment and set up of spare parts management system Input and participate into project design and construction Engineering and maintenance input into design and FAT of new equipment Ensure that maintenance &calibration is carried out in accordance to cGMP regulations, safety considerations and site quality standards. Ensure that CMMS system is maintained current for all running assets on site
Control and regulation of maintenance and repairs budget in excess of €500K
EDUCATION AND EXPERIENCE
A relevant third level qualification in either Engineering or Science or equivalent GMP work experience in Bio-pharmaceuticals or equivalent industry Strong knowledge of cGMP compliance required Experience in developing, implementing and improving maintenance and reliability programs Experience with clean and black utilities as well as strong aptitude to engineering systems and equipment Proficient in the use of reliability excellence methodologies Proficiency with standard office software applications, including MS Word, Adobe Acrobat, MS Access, MS Excel, MS Power Point expected Experience and proficiency with CMMS systems such as EAM, or SAP
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.