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 MaintenanceCalibration 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.