Calibration Supervisor

The Calibration Supervisor is responsible for leading day-to-day Calibration department activity to ensure that routine and non-routine instrument calibrations are performed on schedule and within established tolerances.

The Calibration Supervisor and supporting technicians are responsible for performing all levels of calibration (basic to complex), maintaining calibration records and notifications, creating and modifying procedures, selecting and maintaining standards and test equipment, and troubleshooting and repairing mechanical/electrical devices. The Calibration Supervisor will report into the A.D. of Automation at Lantheus’ Billerica, MA manufacturing facility

Essential Functions

• Mentoring and supervising calibration team – including bi-annual review, work order review, providing development and training opportunities, and transferring knowledge & experience
• Coordinating external calibrations
• Coordinating with asset owners to complete calibration activities or issue extensions
• Reviewing or owning deviation investigations related to failed/late calibrations and quality events
• Specifying and maintaining calibration standards and metrology test equipment
• Performing independent routine and non-routine calibrations of all laboratory, manufacturing, and radiation monitoring equipment following SOP’s and in accordance with cGMP’s
• Accurately following oral and written procedures to calibrate both simple and complex equipment
• Collecting and compiling accurate data from calibration software to document calibrations and prepare reports
• Efficiently and effectively maintaining processes that are basic to the Metrology Group function, e.g. history records, shipping/receiving, scheduling, customer notifications, etc.
• Testing, troubleshooting, and repairing electronic, electromechanical, and advanced diagnostic devices
• Accessing and adjusting a variety of process controllers and control systems
• Creating, modifying, and reviewing SOP’s for continual improvement of the calibration program
• Independently representing the Metrology organization on validation and cross functional teams
• Initiating and executing validation and other major projects within the Metrology group
• Managing the technical and professional development of new and junior technicians
• Reviewing and approving records compiled by calibration technicians
• Using advanced knowledge of industry standards (calibration frequency, ranges, and limits), to review and approves requests for new calibration items
• Actively promoting safety rules and awareness. Demonstrating good safety practices at all times including the appropriate use of protective equipment. Reporting and taking initiative to correct safety and environmental hazards.
• Actively demonstrating the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety, and teamwork

Typical Minimum Skills and Experience and Education

• AS in electronics or equivalent and formal advanced Metrology training with a minimum of 8 years of calibration experience in a GMP manufacturing environment.
• A combination of education, training, and experience may be considered in lieu of above stated requirements.

Other Requirements

• Specialized knowledge in performing calibration tasks that are not fully described in standardized procedures
• Experience with people-management either directly or indirectly
• Industrial experience with electronics testing and repair at system, board, and component level
• Expert knowledge of temperature, pressure, flow, and other calibration principles as well as cGMP’s and quality principles as they pertain to the biotech/pharmaceutical industry
• Minimum of 8 years calibration experience with 3 years electronics troubleshooting
• Detailed understanding of pharmaceutical industry cGMP principles and requirements
• Experience recognizing gross deviations from normal results and identifying root cause
• Solid understanding of metrology terminology, methods, applications, and principles as well as electronics theory
• Expert technique and operation of various of advanced calibration standard types
• Experience performing high level problem solving
• Familiar with mathematical calculations to simulate and establish operating parameters
• Previous experience writing technical documents
• Advanced knowledge in the use of calibration standards with traceability to NIST
• Proficient use of computers, calibration software, electronic diagnostic equipment and PLC’s to monitor instrumentation I/O