Automation Systems, Autoscaling, Biotech and Pharmaceutical, Calendar Management, Change Control, Code of Federal Regulations, Commissioning, Communication Skills, Computer Science, Computer Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Equipment Validation, GMP (Good Manufacturing Practices), HVAC, Leadership, Life Insurance, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Management, Manufacturing Systems, Operational Support, Organizational Skills, Process Validation, Risk Analysis, Sales Qualification, System Lifecycle, System Validation, Systems Administration/Management, Systems Engineering, Systems Scalability, Team Player, Technical Leadership, Technical Writing, Time Management, Traceability, Validation Documentation, Validation Plan, Vision Plan
Head of Validation Brighton, Michigan
Biovire is advancing toward commercialization with a focus on operational excellence, compliance, and scalable GMP manufacturing systems. We are seeking a Manager of Validation to lead validation programs supporting equipment, facilities, utilities, and computerized systems within our regulated pharmaceutical manufacturing environment.
This is a highly visible leadership role responsible for ensuring validation programs support operational readiness, inspection readiness, and long-term manufacturing reliability as the organization continues to scale.
The Role
The Manager of Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight for validation strategy, execution, compliance, and lifecycle management of manufacturing systems and infrastructure.
This position partners closely with Quality, Manufacturing, Engineering, Maintenance, and cross-functional operational teams to ensure all systems remain compliant, qualified, and inspection-ready.
Key Responsibilities
- Lead site validation programs supporting equipment, facilities, utilities, and computerized systems
- Oversee commissioning, qualification, and validation activities in accordance with cGMP requirements
- Manage and maintain Validation Master Plans and validation lifecycle documentation
- Lead scheduling, planning, review, and execution of validation activities
- Support transition of equipment and systems from Engineering to operational use
- Partner cross-functionally with Quality, Manufacturing, Engineering, and Maintenance teams
- Provide technical guidance for risk assessments, change controls, deviations, and investigations
- Ensure timely completion of validation protocols, reports, traceability matrices, IQ/OQ documentation, and related deliverables
- Support audit and inspection readiness activities
- Lead and develop validation personnel while reinforcing a strong quality and compliance culture
What You Bring
- Bachelor's degree in Engineering, Science, Computer Systems, or related technical field
- 5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments
- Prior leadership experience within Validation, Engineering, CQV, or Quality functions
- Strong understanding of cGMP, validation lifecycle management, and 21 CFR Part 11 requirements
- Hands-on experience leading validation projects and technical documentation activities
- Experience supporting manufacturing equipment, utilities, HVAC, automation systems, and/or computerized systems
- Strong organizational, communication, and cross-functional collaboration skills
Why Join Biovire
- Opportunity to shape and strengthen validation systems during organizational growth
- High visibility and cross-functional leadership exposure
- Collaborative and mission-driven GMP manufacturing environment
- Direct impact supporting operational readiness and future commercialization
- Company-paid medical, dental, vision, and life insurance
- Paid Time Off supporting work-life balance
Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.