Senior Manager, Maintenance & Calibration Operations SUMMARYThe Senior Program Manager, Maintenance & Calibration reports to the Associate Director, GMP Maintenance and Calibrations and is accountable for the leadership and continuous improvement of site GMP maintenance and calibration programs in compliance with cGMP and regulatory requirements. The role serves as the primary maintenance and calibration interface for capital projects and provides oversight of planning and scheduling, budget and service contract management, MRO Parts, and QC Equipment Management, ensuring all associated quality systems, procedures, and investigations comply with site and regulatory standards.
RESPONSIBILITIES- Serve as the Maintenance & Calibration representative on CAP/Opex projects across all phases of the project lifecycle.
- Manage QC Equipment Management team and associated calibration activities.
- Review and manage departmental budgets, including forecasting, purchase orders, reconciling review, and cost allocation strategies.
- Establish, review, and manage service contracts in collaboration with Legal and Procurement.
- Representative for Facilities departments in a regulatory audit where required
- Perform other duties as assigned in support of Facilities and Engineering objectives.
EXPERIENCERequired Skills- Strong knowledge of cGMP requirements, quality systems, and regulatory expectations.
- Proven ability to manage budgets, service contracts, and vendor performance.
- Experience driving business process improvements in maintenance, calibration, or engineering functions.
EDUCATIONEQUIPMENTCONTACTS- External: Equipment vendors, maintenance and calibration service providers, and engineering contractors.
SUPERVISOR RESPONSIBILITYSHIFT DETAILSONSITE, REMOTE, OR FLEXIBLETRAVEL REQUIRED
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.
About Technical Operations
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.
