Maintenance Reliability Engineer
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 Reliability Engineer reports to the Manager, Engineering and Reliability and will be responsible for ensuring that all maintenance and reliability systems are implemented and operated in an efficient manner with a focus on continuous development. The Maintenance Reliability 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
- 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
- Completion of equipment FMEA exercises to develop, streamline and improve maintenance and reliability programs at BioMarin
- Liaise with colleagues on other BioMarin sites to leverage and share best practice.
- Consistent use of lean and six sigma tools such as root cause analysis, DMAIC, 5S, right first time and Standard work. Champion and support all team projects in these areas.
- 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
- 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 reliability metrics
- Ensure that all cGMP safety training is completed prior to engaging in any activities
- Oversight of site maintenance service contracts, implementing KPI’s to ensure services completed and compliant and cost effective
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
- Other duties as assigned.
Experience & Skills
- A minimum of 5 years’ experience in the bio-pharmaceutical industry with strong technical, Asset Lifecycle Management and/or maintenance experience
- Sterile filling experience.
- Strong demonstrated ability in the area of communication and strong ability to interact with cross-functional teams.
- Experience with CAPA, FMEA and RCA tools is a highly regulated operations environment.
- Creative problem-solving skills, with the ability to make decisions and take necessary actions.
- Strong organizational skills, as well as the ability to manage multiple priorities.
- A relevant third level qualification in Science, Engineering or related discipline is preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.