Calibration Lead
On-siteBrighton, Michigan, United States
Job Summary
Conduct daily calibration, verification, adjustment, and functional testing on manufacturing equipment, utilities, and facility systems while troubleshooting instrumentation and automated control issues. Coordinate and prioritize calibration activities across internal and external resources, manage third-party vendor coordination, and maintain accurate GMP-compliant records. Serve as the primary site contact for compliance, audit support, and inspection readiness, providing technical guidance on calibration standards and instrumentation practices. Support preventive maintenance, equipment reliability, commissioning, and operational readiness initiatives for a large-scale GMP calibration program involving 500+ assets. Partner cross-functionally with Manufacturing, Quality, Validation, and Engineering teams to support investigations related to out-of-tolerance instruments and deviations.
Required Qualifications
- 5+ years of hands-on calibration experience within pharmaceutical, biotechnology, or other regulated manufacturing environments
- High School Diploma or equivalent
- Ability to clearly articulate calibration methodologies, troubleshooting logic, and GMP-compliant execution practices
- Demonstrated organizational skills with ability to manage multiple calibration activities, priorities, vendors, and compliance requirements simultaneously
- Ability to read and interpret electrical, instrumentation, and P&ID drawings
- Ability to independently coordinate and execute calibration activities supporting a large multi-asset manufacturing environment
- Experience troubleshooting automated systems and utilities
- Strong troubleshooting, technical documentation, and GMP/GDP documentation skills
- Problem-solving skills and attention to detail
- Ability to work independently and collaboratively as part of a team
- Employment at Biovire is contingent upon a successful Background check
Desired Qualifications
- technical certification or trade school
- Experience serving as a lead technician, technical coordinator, or subject matter expert
- Experience supporting OOT investigations, CAPAs, deviations, and change controls
- Experience supporting regulated calibration documentation including deviations, investigations, CAPAs, and change controls
- Experience working with NIST-traceable calibration standards, regulated calibration documentation practices, and instrument tolerance evaluation
- Familiarity with PLC systems (Allen-Bradley preferred)
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