Natick, MA /
The successful candidate will be responsible for oversight of our equipment program. This is an onsite position that's based in Natick, MA.
- 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
- 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
- Work with equipment owners to ensure successful completion of IQ/OQ/PQ
- Perform qualifications of all cold storage units and temperature loggers
- 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
- Assess current program and associated processes to determine areas of improvement.
- Determine future needs to support company growth.
Calibration and Preventative Maintenance
- 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
- 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
Knowledge, Skills, and Abilities:
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.