Instrumentation Team Lead

2 weeks ago

Novato, California, United States Biomarin Full time

About Us

At BioMarin, our Technical Operations team is dedicated to the development and production of innovative therapies for clinical and commercial use. Our skilled engineers, technicians, and scientists work collaboratively to maintain and enhance our state-of-the-art manufacturing processes, ensuring compliance with regulatory standards while facilitating the global distribution of our life-saving products.

Position Overview: Instrumentation Team Lead

SUMMARY

This role is a Day Shift position, operating Monday through Friday. Under the guidance of the Associate Director of GMP Maintenance and Calibration, the Instrumentation Team Lead will oversee a team responsible for the calibration of instruments within a cGXP environment, which includes Facilities, Quality Control, Validation, and Manufacturing Departments. The Team Lead will manage staff activities, perform calibrations, develop and update calibration procedures, and conduct department-specific training. Additionally, this position will ensure comprehensive documentation of all calibration activities while adhering to current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies, and safety protocols.

Key Responsibilities

Leadership

  • Oversee daily operations in Instrumentation, requiring effective communication for decision-making, troubleshooting, and adherence to schedules with minimal supervision.
  • Ensure all routine calibrations are completed on time.
  • Coordinate tasks efficiently through direct engagement.
  • Provide guidance and hands-on training to team members.
  • Participate in the management and development of staff.
  • Promote departmental values and set performance standards for the team.
  • Encourage a culture of compliance, ethics, and professional growth.

Contribution

  • Engage in moderate-level projects effectively.
  • Collaborate with peer Leads across various departments to foster alignment and drive improvements.
  • Work in partnership with support groups (Manufacturing, Validation, Quality) to fulfill scheduled tasks.

Process Knowledge

  • Possess strong knowledge and experience in calibration theory, equipment, operation, and compliance.
  • Demonstrate the ability to troubleshoot, identify issues, and support resolutions with technical teams.
  • Perform ongoing operational tasks within the designated work area.
  • Utilize scientific reasoning and decision-making in daily responsibilities.

Technical Competency

  • Exhibit proven experience with instrumentation processes, theories, and equipment.
  • Experience with process automation and functionality is advantageous.
  • Assist in the review and approval of documentation, including SOPs, Work Orders, and logbooks.
  • Support the resolution of Facilities-related Quality Records (deviations, change requests).

Quality and Compliance

  • Maintain a comprehensive understanding and adherence to cGMPs as they relate to Instrumentation.
  • Initiate and manage necessary Corrective and Preventative actions and lead change control processes.
  • Assist in resolving Facilities discrepancies and change requests while staying current with FDA and EMEA guidelines, and cGMP regulations.

Business Acumen

  • Experience with business systems (CMMS, Trackwise, ERP, etc.).
  • Support the tracking and communication of defined departmental metrics.
  • Identify and pursue opportunities for process and business optimization.
  • Translate company and departmental objectives into actionable goals for self and team members.

Qualifications

  • High School Diploma is required; college-level coursework is preferred.
  • 6+ years of relevant industry experience, including a minimum of 2+ years in a leadership role.
  • Ability to independently manage work, actions, and expectations is essential.
  • Demonstrated technical expertise in instrumentation and calibration systems.
  • Strong organizational, collaborative, and communication skills.
  • May supervise 5 or more direct reports.

Equal Opportunity Employer

BioMarin is 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.

Compensation

The salary range for this position is competitive and will be determined based on various factors, including geographic region, job-related knowledge, skills, and experience.

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