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.
• 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 practices
• 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
• Management of multiple service contracts
• Control and regulation of maintenance and repairs budget in excess of €700K
EDUCATION AND EXPERIENCE
• A relevant third level qualification in either Engineering or Science or equivalent GMP work experience in Bio-pharmaceuticals or equivalent industry. 8 Years Industry experience.
• 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
WORK ENVIRONMENT / PHYSICAL DEMANDS
• All areas of site business, primarily QA, QC, EHS, MFG, FF, MSAT and Utilities.
• No direct reports
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.