Summary of Responsibilities:
Plan and schedule all Calibration and Preventive Maintenance (PM) work to be performed at the Bedford Manufacturing Site. Oversee all aspects of the GMP asset life-cycle program from onboarding to retirement including calibration, preventive and emergency maintenance.
- Schedule Calibration and PM activities in coordination with end-user departments ensuring minimal impact to operating schedules
- Determine calibration specifications and complete out-of-tolerances in collaboration with appropriate departments
- Manage third parties performing equipment calibration and maintenance services including reviewing/accepting vendor documentation
- Own GMP asset management program including acting as system administrator of the Computerized Maintenance Management System (CMMS)
- Support audits, inspections, and regulatory submissions
- Provide quarterly metrics indicating overall calibration status through the year
- Support development of annual calibration budgets
- Other duties as assigned
- Associates or Bachelor’s degree.
- Minimum of 4 years of experience in a GMP equipment calibration/maintenance role
- In-depth understanding of calibration principles and maintenance best practices
- Prior experience with CMMS
Ability to interpret and communicate complex information in a fast paced, regulated environment. A high level of focus and self-management is imperative to the success of this role.