Calibration Lead

Job Description

Job Description

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 RoleThe 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 ResponsibilitiesPerform calibration, verification, adjustment, and functional testing activities on manufacturing equipment, instrumentation, utilities, and facility systemsTroubleshoot instrumentation, electrical, automated, and control-related system issuesCoordinate and prioritize daily calibration activities across internal and external resourcesServe as the primary site contact for calibration-related compliance, audit support, and inspection readiness activitiesProvide technical guidance and mentoring regarding calibration standards, instrumentation practices, and documentation expectationsSupport preventive maintenance and equipment reliability initiativesAssist with commissioning, qualification, and operational readiness activitiesMonitor and support Building Automation Systems and utility infrastructureMaintain accurate GMP/GDP-compliant calibration records, work orders, and maintenance documentationCoordinate 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 functionsPartner cross-functionally with Manufacturing, Quality, Validation, and Engineering teamsSupport safe, compliant, and organized operations across the site What You Bring5+ years of hands-on calibration experience within pharmaceutical, biotechnology, or other regulated manufacturing environmentsHigh School Diploma or equivalent required (technical certification or trade school preferred)Experience coordinating calibration programs, third-party vendors, and compliance documentationExperience serving as a lead technician, technical coordinator, or subject matter expert preferredExperience supporting OOT investigations, CAPAs, deviations, and change controlsExperience supporting regulated calibration documentation including deviations, investigations, CAPAs, and change controls preferredExperience working with NIST-traceable calibration standards, regulated calibration documentation practices, and instrument tolerance evaluationAbility to clearly articulate calibration methodologies, troubleshooting logic, and GMP-compliant execution practicesDemonstrated organizational skills with ability to manage multiple calibration activities, priorities, vendors, and compliance requirements simultaneouslyAbility to read and interpret electrical, instrumentation, and P&ID drawingsAbility to independently coordinate and execute calibration activities supporting a large multi-asset manufacturing environment Experience troubleshooting automated systems and utilitiesFamiliarity with PLC systems (Allen-Bradley preferred)Strong troubleshooting, technical documentation, and GMP/GDP documentation skillsProblem-solving skills and attention to detailAbility to work independently and collaboratively as part of a team Why Join BiovireCompany-sponsored medical, dental, vision, and life insurancePaid Time Off for strong work-life balanceCollaborative and mission-driven environmentOpportunity 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.