Director, Validation

Director, Validation Brighton, Michigan

Biovire is advancing toward commercialization with a focus on operational excellence, technical capability, compliance, and scalable GMP manufacturing systems. We are seeking an experienced Director, Validation , reporting to the Vice President of Engineering, to provide strategic and technical leadership for Validation across our Brighton manufacturing site.

This is a highly visible leadership role responsible for establishing and executing Biovire's site validation strategy across Commissioning, Qualification and Validation (CQV) and Computer System Validation (CSV) . The Director will build organizational capability, strengthen validation governance, and ensure manufacturing equipment, facilities, utilities, automation, and computerized systems remain qualified, validated, compliant, and inspection-ready throughout their lifecycle.

The Role

The Director, Validation serves as Biovire's senior Validation leader and Subject Matter Expert, partnering closely with Engineering, Quality, Operations, Manufacturing, Maintenance & Calibration, IT, and other stakeholders as the organization expands and prepares for commercialization.

This leader will provide technical and organizational leadership across two major areas of validation expertise: Equipment, Facilities & Utilities Qualification and Computer Systems Validation. The Director will assess and develop the appropriate internal capabilities, technical SMEs, external resources, standards, and governance needed to support a sustainable site-wide Validation program.

The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and responding directly to technical questions.

Key Responsibilities

• Establish and execute the site-wide Validation strategy across equipment, facilities, utilities, automation, and computerized systems.
• Own the Validation Master Plan and overall validation governance framework, ensuring alignment with regulatory expectations, business priorities, site expansion, and commercialization readiness.
• Provide strategic and technical leadership for CQV and CSV, including appropriate lifecycle governance and maintenance of the validated state.
• Build and develop organizational capability across Equipment, Facilities & Utilities Qualification and Computer Systems Validation.
• Recruit, lead, coach, and develop technically strong Validation professionals and SMEs while establishing clear accountability and development pathways.
• Serve as Biovire's senior Validation SME during FDA and other regulatory inspections and client audits, including preparation, presentation and defense of validation strategies, and responses to technical questions.
• Provide technical leadership for commissioning, startup, site expansion, technology transfer, process validation, and implementation of new manufacturing equipment and systems.
• Establish and oversee the Computer Systems Validation program, including application of GAMP 5, data integrity principles, electronic records/signatures requirements, and 21 CFR Part 11.
• Provide technical oversight for validation plans, protocols, reports, traceability matrices, risk assessments, IQ/OQ/PQ documentation, qualification activities, and related deliverables.
• Partner with Quality and Operations to ensure manufacturing systems transition effectively from Engineering into operational use and remain qualified and inspection ready.
• Provide Validation leadership for risk assessments, change controls, deviations, discrepancies, investigations, and integration with CAPA and other Quality Systems.
• Establish appropriate governance and technical oversight for validation contractors, consultants, vendors, and other external resources while developing sustainable internal capability.
• Continuously assess Validation program health, identify technical and compliance risks, establish priorities, and drive sustainable improvement.
• Build a culture of technical excellence, ownership, collaboration, accountability, inspection readiness, and continuous improvement.

What You Bring

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or another related technical discipline required; advanced degree preferred.
• 10+ years of progressive Validation, Engineering, Quality, or related technical experience within pharmaceutical, biopharmaceutical, biotechnology, medical device, or another similarly regulated environment, including significant leadership responsibility.
• Prior direct people leadership experience with demonstrated success developing technical professionals and building organizational capability.
• Significant hands-on technical experience with equipment, facilities, and utilities commissioning and qualification, including IQ/OQ/PQ and risk-based qualification methodologies.
• Demonstrated experience with Computer Systems Validation, GAMP 5, data integrity principles, and 21 CFR Part 11.
• Strong knowledge of GMP manufacturing processes, process equipment, critical utilities, automation, computerized systems, and validation lifecycle management.
• Demonstrated experience developing, critically reviewing, approving, and defending complex validation strategies and technical documentation.
• Demonstrated experience serving in a technical leadership or SME capacity during FDA or other regulatory inspections and client audits, including presenting and defending validation strategies and responding directly to technical questions.
• Experience managing complex validation programs, consultants, contractors, vendors, and external technical resources.
• Ability to read and interpret architectural, mechanical, electrical and process drawings, P&IDs, equipment specifications, system architecture, and related technical documentation.
• Strong executive communication, organizational, people leadership, program management, and cross-functional collaboration skills.

Why Join Biovire

• Lead and shape a critical technical function as Biovire prepares for commercialization.
• Build Validation capability and governance across both CQV and Computer Systems Validation.
• Play a direct leadership role in site expansion, operational readiness, and regulatory inspection readiness.
• Work cross-functionally with senior leaders across Engineering, Quality, Operations, and Manufacturing.
• Opportunity to build and develop technical talent and sustainable organizational capability.
• Company-paid medical, dental, vision, and life insurance.
• Paid Time Off supporting work-life balance.
• Collaborative, mission-driven GMP pharmaceutical manufacturing environment.

Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.