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.
Specific Responsibilities:
- 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
Required Qualifications:
- 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
Job Complexity:
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.
Supervisory Responsibilities:
None
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.