Equipment Coordinator

Natick, MA /
Operations /
Full time
The successful candidate will be responsible for oversight of our equipment program. This is an onsite position that's based in Natick, MA.

Responsibilities

    • Enroll manufacturing/processing equipment for labs and/or warehousing and distribution.
    • Track and tag all assets
    • Maintain all associated records in the electronic quality management system per established procedures
    • Set-up external calibration and maintenance contracts, schedule services, initiate purchase orders
    • Schedule equipment repairs
    • Requisition equipment, materials, or parts
    • Revise or generate procedures
    • Calibration and Preventative Maintenance
    • Ensure maintenance and calibration are performed on time as required per calibration and maintenance procedures, and that the schedules are met.
    • Notify responsible personnel/user of upcoming calibration and maintenance due dates
    • Review calibration and maintenance reports to ensure compliance and results
    • Track and trend calibration and maintenance data. 
    • Review change orders related to calibration and maintenance
    • Equipment Qualifications
    • Work with equipment owners to ensure successful completion of IQ/OQ/PQ
    • Perform qualifications of all cold storage units and temperature loggers
    • Monitoring
    • Monitor and manage cold storage systems. 
    • Review temperature data on a regular basis.  Present data at infrastructure meetings.
    • Respond to cold storage out of specification alarms
    • Maintain an understanding of internal processes, industry standards and best practices.
    • Ability to identify issues, present complex problems with possible solutions, and actively takes leadership role to resolve of issues.
    • Initiate Non-Conforming Material Report if equipment is found to be out of tolerance during calibration or any time during use
    • Support verification/validation activities for new equipment or based on need
    • Support internal and external audits and inspections
    • Report unsafe conditions
    • Support projects or activities as required by the company
    • Perform other duties or special projects as assigned by management
    • Strategic Responsibilities
    • Assess current program and associated processes to determine areas of improvement.
    • Determine future needs to support company growth.

Qualifications

    • Bachelor’s degree or higher in engineering field with a minimum of 5 years’ experience managing equipment within a regulated environment
    • Experience working in ISO 13485 Certified or FDA regulated environments
    • Molecular diagnostics experience is preferred
    • Knowledge of FDA and ISO requirements pertaining to calibrations and maintenance, and control and monitoring of Measuring Devices
    • Experience with cold storage unit monitoring and management
    • Knowledge, Skills, and Abilities:
    • Ability to work within a team-based environment
    • Excellent communication (written and oral) skills
    • Experience working in a regulated environment
    • Detail oriented with excellent organizational skills
    • Excellent Oral and written communication skills
    • Proficient with MS Office Suite (Outlook, Excel, and Word)
    • Knowledge of Good Documentation Practices
    • Ability to understand and interpret tolerances
Pillar Biosciences aims to "Make precision medicine the first option for every patient" by developing and manufacturing targeted next-generation sequencing (NGS)-based assays and software for today’s high-throughput specialty NGS laboratories. We are seeking collaborative and independent problem solvers to support our mission.

Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.