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Facilities Scheduling & Compliance Coordinator (TEMPORARY)

Location Novato, California
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. 

Duties


The position is responsible for providing a wide range of critical support for Facilities Services in the Maintenance Business Office (MBO). 



Responsibilities:




    • Administration of the SAR (System Area Release) process




        • The SAR process is used to take GxP systems temporarily out of service and return them into use in a controlled manner. (GxP systems include process equipment, clean rooms, and utilities)



        • Day-to-day management and tracking of SARs to completion



        • Daily email communication to a wide audience on SAR updates



        • Working with Facilities planning and scheduling team to ensure SARs are in place for routine maintenance and repair tasks



        • Training workforce on the SAR process





    • Work cross functionally with manufacturing on scheduling maintenance tasks



    • Monitor and manage inboxes in CMMS



    • Participation in daily manufacturing planning meeting to asses impacting and non-impacting work



    • Work to eliminate excessive downtime to manufacturing by combining work when possible



    • Contact and collaborate with external vendors to schedule work onsite



    • GxP Pest Control: Responsible for managing contractor routine site visits, contractor training, and change requests/deviations/preventive maintenance related to the system. Also maintains paper records and metrics for audit purposes



    • Adherence and administration of SOP’s (Standard Operating Procedures)



    • Maintain personal training record with no assignments past due



    • CMMS (Computer Maintenance and Management System): Ability to initiate work orders and notifications. Must develop advanced knowledge of the system, including report generation and ability to research equipment history



    • Other duties as requested by Facilities management, or to support the team


Skills




    • Strong computer literacy: highly fluid and proficient with Office software (Outlook, Word, Excel, PowerPoint at minimum), ability to perform data analysis and graphing in Excel



    • Attention to detail, team player, and must have the ability to respond rapidly and efficiently



    • Some understanding of GMP systems and manufacturing processes



    • Ability to quickly learn and master software used for management of Facilities Operations (e.g. CMMS, Pi Historian, SCADA) and Quality Systems (e.g. Trackwise, VEEVA)



Education



    • Bachelors of Arts/Science Degree (Engineering, Operations, Supply Chain, or Scientific Field Preferred)

    • A combination of technical, military, and/or equivalent experience can be used in lieu of degree

    • Work experience in heavily regulated industry Ideal

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.



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.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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