Allen-Bradley, Automation Systems, Background Investigation, Biotech and Pharmaceutical, Calibration, Change Control, Commissioning, Communication Skills, Cross-Functional, Detail Oriented, Documentation, Drug Manufacturing, Electricity, Establish Priorities, Functional Testing, GMP (Good Manufacturing Practices), High School Diploma, Home Automation, Identify Issues, Instrumentation, Life Insurance, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Mentoring, Organizational Skills, Preventative Maintenance, Problem Solving Skills, Programmable Logic Controller (PLC), Project/Program Coordination, Quality Engineering, Regulatory Compliance, Support Documentation, System Operations, Team Player, Technical Leadership, Technical Support, Technical Writing, Time Management, Tolerance Analysis, U.S. National Institute of Standards and Technology (NIST), Vision Plan
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.