Metrology Manager II
Company: UMass Biologics
Posted on: January 27, 2023
Metrology Manager II
3 months ago(10/17/2022 10:57 AM)
# of Openings
GENERAL SUMMARY OF POSITION: The Metrology Operations Manager II is
responsible for managing the work of the Metrology group across
multiple sites to ensure that the instrumentation is calibrated in
compliance with current Good Manufacturing Practices (cGMP)/current
Good Laboratory Practices (cGLP) and industry standards. Performs
both hands-on calibration and supervisory functions. The individual
is responsible for delivering FDA compliance and excellent customer
service in a 24-hour manufacturing environment within a prescribed
budget. This is a performance based position where success is
measured through the achievement of organizational and departmental
MAJOR RESPONSIBILITIES:Manages metrology program for FDA licensed
manufacturing facility and associated research and development
operations. This includes:
- Calibration, troubleshooting and
repair of a variety of complex analytical instruments.
- Development of calibration methods.
- Generation, review and revision of calibration SOPs.
- Scheduling and documentation of calibration activities through
a computerized maintenance management system (CMMS).
- Ensures standardization of metrology procedures across multiple
- Develops and maintain management metrics for metrology
- Develops training programs for metrology personnel. Provides
specialized training for specific tasks / equipment as needed.
- Specifies and procures metrology related tools, standards,
instruments and equipment.
- Adheres to budgets, schedules and performance
- Negotiates and manages multiple contracts with outside vendors
performing calibrations on various types of equipment.
- Maintains calibration records, instrument identification and
- Writes and implements change controls to maintain cGMP
- Writes incident/deviation reports as necessary, performing root
cause analyses and identifying corrective actions as
- Manages employee performance and provide coaching and mentoring
of direct reports .
- Serve as technical advisor on instrumentation issues.
- Performs additional job related duties as required.
- BS degree preferably in a scientific discipline or
- Minimum of 5-7 years relevant experience including management
- Executes assignments with minimal supervision/direction.
Capable of concurrently executing and managing a variety of
projects. Demonstrated excellent time management and organization
- Exercises judgment within defined procedures and policies to
determine appropriate action
- Demonstrated capability to manage others, assign and schedule
work, and conduct performance evaluation
- Knowledgeable of pharmaceutical/biotechnology process
instruments, equipment, and related facility unit operations.
Well-versed in current Good Manufacturing Practices.
- Demonstrated excellent communication skills, both written and
verbal, as well as ability to communicate with individuals in all
levels of the organization
- Experience in all aspects of Calibration/Metrology processes.
Requires a thorough understanding of metrology principles defined
- May require frequent travel between the JP and Mattapan
- Ability to ensure 24-hour operations which may dictate
irregular work schedules based on business needs
- Ability to lift fifty (50) pounds with proper lifting
Keywords: UMass Biologics, Boston , Metrology Manager II, Executive , Mattapan, Massachusetts
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