Supervisor, Instrumentation (Swing Shift)
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.
Under direction of Facilities Management, the Instrumentation Supervisor will be responsible for leading a team of individuals in the calibration of instruments in the cGXP environment, including Facilities, Quality Control, Validation, and Manufacturing Departments. The Supervisor is accountable for managing the activities of the staff, performing calibrations, writing and revising calibration procedures and conducting or coordinating department specific training. Additionally the Supervisor will oversee complete documentation of all required calibration activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies and safety practices.
− Accountable for the daily operations in Metrology which requires a high level of communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
− Accomplishes tasks through direct and effective coordination
− Provides direction and hands-on training for staff
− Involved in the management of staff
− Lives department values and sets the standards for others to operate
− Fosters an environment of compliance, work ethics and development
− Ability to take on moderate level projects
− Effective interaction with peer Leads across multiple departments to create alignment and improvement
− Partners with support groups (Manufacturing, Validation, Quality) to complete scheduled activities
− Strong knowledge and experience in all aspects calibration theory, equipment, operation and compliance
− Ability to troubleshoot, identify issues and support resolutions with technical groups
− Required to perform ongoing operational tasks in respective work area
− Uses scientific thinking and decision making in daily work
− Proven experience with instrumentation process, theory and equipment
− Experience with process automation and functionality a plus
− Assist with review and approval of documentation including SOPs, Work Orders, and logbooks
− Support the closure of Facilities owned Quality Records (deviations, change requests)
Quality and Compliance
− Complete understanding and adherence to cGMP’s as related to Metrology and Calibration
− Initiate and own required Corrective and Preventative actions and lead change control actions
− Support the closure of Facilities discrepancies and change requests
− Current understanding of FDA and EMEA guidelines, cGMP's
− Experience business systems (CMMS, Trackwise, ERP, etc.)
− Support trending and communication of defined department metrics
− Identify and drive opportunities for process & business optimization
− Translates company and department goals into actionable objectives for self and staff
− High School Diploma is required.
− College level courses are desired.
− 6+ years of directly related industry experience, including at least 2+ years with proven leadership role
− Ability to independently manage work, actions and expectations is essential
− Demonstrated technical expertise in instrumentation and calibration systems
− Strong organizational, collaborating and communication skills
− May have 5 or more direct reports to supervise
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.