Calibration Lead

Calibration Lead Brighton, Michigan

Biovire is advancing toward commercialization with a focus on quality, operational excellence, and reliable manufacturing performance within a GMP-regulated environment. Our Maintenance & Calibration team plays a critical role in supporting manufacturing equipment, utilities, instrumentation, and facility systems that enable life-changing therapies.

The Role

The Calibration Lead serves as the primary site resource for coordination of a large-scale GMP calibration program involving 500+ manufacturing, utility, and facility assets. This role is responsible for supporting execution and coordination of a large-scale GMP calibration program, including onsite and offsite calibration activities, instrumentation support, compliance documentation, vendor coordination, and operational readiness across the Brighton site.

This is a hands-on technical role supporting manufacturing operations, utilities, automated systems, and operational readiness initiatives in a fast-paced pharmaceutical manufacturing environment.

Key Responsibilities

• Perform calibration, verification, adjustment, and functional testing activities on manufacturing equipment, instrumentation, utilities, and facility systems
• Troubleshoot instrumentation, electrical, automated, and control-related system issues
• Coordinate and prioritize daily calibration activities across internal and external resources
• Serve as the primary site contact for calibration-related compliance, audit support, and inspection readiness activities
• Provide technical guidance and mentoring regarding calibration standards, instrumentation practices, and documentation expectations
• Support preventive maintenance and equipment reliability initiatives
• Assist with commissioning, qualification, and operational readiness activities
• Monitor and support Building Automation Systems and utility infrastructure
• Maintain accurate GMP/GDP-compliant calibration records, work orders, and maintenance documentation
• Coordinate third-party calibration vendors and external service providers to support compliant and timely execution of calibration activities
• Support investigations related to out-of-tolerance (OOT) instruments, calibration discrepancies, and related GMP events in partnership with Quality and Engineering support functions
• Partner cross-functionally with Manufacturing, Quality, Validation, and Engineering teams
• Support safe, compliant, and organized operations across the site

What You Bring

• 5+ years of hands-on calibration experience within pharmaceutical, biotechnology, or other regulated manufacturing environments
• High School Diploma or equivalent required (technical certification or trade school preferred)
• Experience coordinating calibration programs, third-party vendors, and compliance documentation
• Experience serving as a lead technician, technical coordinator, or subject matter expert preferred
• Experience supporting OOT investigations, CAPAs, deviations, and change controls
• Experience supporting regulated calibration documentation including deviations, investigations, CAPAs, and change controls preferred
• Experience working with NIST-traceable calibration standards, regulated calibration documentation practices, and instrument tolerance evaluation
• 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
• Familiarity with PLC systems (Allen-Bradley preferred)
• 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

Why Join Biovire

Company-sponsored medical, dental, vision, and life insurance

Paid Time Off for strong work-life balance

Collaborative and mission-driven environment

Opportunity to grow technical expertise within pharmaceutical manufacturing

Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.

Employment at Biovire is contingent upon a successful Background check.