Manager/Supervisor, Metrology

Role Summary

Manager/Supervisor, Metrology responsible for leading the calibration program, driving best practices, and ensuring compliance with cGMP and applicable regulatory standards. Oversees staff development, system ownership of the BMRAM database, and coordination of calibration and preventive maintenance activities across manufacturing and laboratory environments.

Responsibilities

• Lead the calibration function, drive best practices, and define and maintain the calibration program. Ensure that all work is performed in a compliant manner ensuring that activities meet all quality standards for cGMP and other applicable regulatory agencies.
• Manage, motivate, and mentor the staff to continuously improve skills and team performance. Lead by example, recognize and celebrate successes. Encourage teamwork to ensure productivity goals are met or exceeded.
• Serve as system owner of the computerized maintenance database (BMRAM). Ensure timely entry for calibration records, notify the instrument owners of any Out of Tolerance issues, approve calibration activities, report on calibration and maintenance items to show items coming due, overdue, etc., and maintain BMRAM system with assistance from IT.
• Organize and prioritize staff and workload to meet or exceed productivity metrics. Ensure all staff are adequately trained on and act in accordance with cGMP, quality, and safety standards. Responsible for ensuring calibration contractors are technically qualified to perform their assigned tasks.
• Obtain proposals/quotes from vendors/contractors for work done by department. Ensure project/department milestones/goals are met and adhere to approved budgets, including contracted services.
• Responsible for coordinating and scheduling calibration and PM activities on manufacturing equipment, laboratory instrumentation, and utility systems.
• Provide assistance with procurement and setup of instrumentation and manage instrumentation lifecycle. Partner with internal instrument owners to ensure Equipment/Instrument Master Files are generated and maintained.
• Identify problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors and make recommendations for resolution or change to avoid recurrence.
• Sugest and implement continuous improvement and operational excellence methods and tools to improve the overall efficiency of calibration operations.
• Work and interact effectively with cross-functional teams, including Facilities, Engineering, Quality, and Manufacturing, to ensure proper functionality of instrumentation.

Qualifications

• Supervisor, Metrology: Required: Bachelor’s in engineering, Life Sciences or related field or equivalent amount of experience; Required: 4 years of related experience.
• Manager, Metrology: Required: Bachelor’s in engineering, Life Sciences or related field or equivalent amount of experience; Required: 6 years of related experience; Required: 1 year of direct supervisory experience.

Knowledge, Skills And Abilities

• Solid understanding of cGMP and metrology systems
• Strong knowledge of industry standards and guidelines, such as ISO, ISPE Baseline Guides and CFRs
• Scheduling and schedule tracking experience
• Must work and interact effectively and professionally with others
• Must have effective oral and written communication skills
• Willingness to work with a hands-on approach in managing the calibration function
• Excellent problem solving skills
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Computer skills: MS Office Suite, BMRAM
• Demonstrated ability to manage consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy and procedures

Supervisory Responsibilities

• Manages the calibration group, including employees and contractors that perform on-site calibration services.

Preferred Qualifications

• Understanding and knowledge of Process Equipment and Clean Utility Systems used in Biopharmaceutical manufacturing
• Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for calibration services
• General knowledge of the instrumentation typically used in a Biopharmaceutical manufacturing plant