Description

Who We Are

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.

Supervisor, Instrumentation

 
SUMMARY

This is a Day Shift position operating M-F 0700-1530. Under direction of the Associate Director, GMP Maintenance and Calibration, 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.

RESPONSIBILITIES
Leadership
Accountable for the daily operations in Instrumentation which requires a high level of communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight.
Accountable for all routine calibrations due.
Accomplishes tasks through direct and effective coordination. 
Provides direction and hands-on training for staff. 
Involved in the management and development of staff. 
Lives department values and sets the standards for others to operate.
Fosters an environment of compliance, work ethics and development.

Contribution
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.

Process Knowledge
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.

Technical Competency
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 Instrumentation.
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. 

Business
Experience with 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.
~This role directly handles and/or is in proximity to lentiviral or other viral vector based gene delivery systems.

EDUCATION
High School Diploma is required. 
College level courses are desired.

EXPERIENCE
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.

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.