CMMS Calibration Coordinator

Job Code:

M1045

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Post Date:

November 18, 2021

JOB DESCRIPTION

Execute the maintenance and calibration strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Validation, Quality and business strategies.  Develop, Asset, Maintenance and Calibration documentation to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.  Hands-on contributor capable of managing the coordination effort of all maintenance and calibration activities within the facility utilizing outside vendors and resources. 

Capable of understanding the maintenance and calibration programs as well as requirements in the regulated industry.   Knowledge of current GXP asset management, maintenance and calibration expectations a bonus.

RESPONSIBILITIES

  • Assist or manage implementation of critical computerized maintenance and calibration systems.

  • Advanced understanding of asset management, facilities and equipment maintenance and calibration systems.

  • Develop and review Maintenance plans and reports.

  • Responsible for the creation of asset files.

  • Responsible for the creation of calibration files.

  • Responsible for the planning, tracking and recording of asset lifecycle (asset inception, planned maintenance, unplanned maintenance, calibration, etc.).

  • Coordinate vendor maintenance and calibration activities for all applicable equipment/systems in facility.

  • Represent department in Project Team meetings, interact with project teams and cross-functional groups.

  • Address and/or escalate maintenance and calibration problems or trends to senior management.

  • Ensure compliance with appropriate internal and regulatory policies and procedures. This includes product documentation, specifications, and all regulatory requirements.

  • Communicate Calibration requirements, timelines, and resource needs to management.

  • Work closely with the project team members, including Manufacturing, Engineering, Validation and Quality to meet maintenance and calibration needs and requirements.

QUALIFICATIONS

  • Preferred: Minimum of A.A.S. degree in Computer Science or equivalent experience in business setting

  • Optimal: Bachelor’s degree in Computer Science/Engineering or equivalent

  • Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills

  • Hands-on contributor capable of managing the coordination effort of all maintenance and calibration activities within the facility utilizing outside vendors and resources.