Manager, 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, Validation, reporting to the VP, Engineering, 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 RoleThe Manager, 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, Operations, Manufacturing, Engineering, Maintenance, and cross-functional operational teams to ensure all systems remain compliant, qualified, and inspection-ready. Key ResponsibilitiesLead enterprise validation programs supporting equipment, facilities, utilities, automation, and computerized systems across Biovire's GMP manufacturing operations.Oversee commissioning, qualification, and the overall validation strategy and activities.Partner with Operations and Quality to maintain the qualified state of manufacturing systems.Support commercialization, technology transfer, process validation, and startup activities for new manufacturing processes and facilities.Serve as Validation SME during FDA and regulatory inspections.Lead lifecycle management of validation systems.Manage and maintain Validation Master Plans and validation lifecycle documentationLead scheduling, planning, review, and execution of validation activitiesSupport transition of equipment and systems from Engineering to operational usePartner cross-functionally with Quality, Manufacturing, Engineering, and Maintenance teamsProvide technical guidance for risk assessments, change controls, deviations, and investigationsEnsure timely completion of validation protocols, reports, traceability matrices, IQ/OQ documentation, and related deliverablesSupport audit and inspection readiness activitiesLead and develop validation personnel while reinforcing a strong quality and compliance culture What You BringBachelor's degree in Engineering, Science, Computer Systems, or related technical field5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environmentsPrior leadership experience within Validation, Engineering, CQV, or Quality functionsExperience interacting with FDA or other regulatory agencies and supporting inspections.Ability to communicate technical validation concepts during inspections.Strong understanding of cGMP, validation lifecycle management, and 21 CFR Part 11 requirementsHands-on experience leading validation projects and technical documentation activitiesExperience supporting manufacturing equipment, utilities, HVAC, automation systems, and/or computerized systemsStrong organizational, communication, and cross-functional collaboration skills Why Join BiovireOpportunity to shape and strengthen validation systems during organizational growthHigh visibility and cross-functional leadership exposureCollaborative and mission-driven GMP manufacturing environmentDirect impact supporting operational readiness and future commercializationCompany-paid medical, dental, vision, and life insurancePaid Time Off supporting work-life balance Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.