Head of Validation

General Description

The Manager of Validation leads the Commissioning, Qualification and Validation (CQV) and Computer System Validation (CSV) area, ensuring that all equipment, facilities, and utilities are appropriately qualified for use. The Manager serves as the technical oversight of the facility validation program, prioritizes assignments, allocates labor, provides directions and instruction to staff, evaluates their work, writes technical reports, schedules and coordinates validation studies, evaluates results, and proposes alternative validation strategies.

The role participates in audits, engaging with clients and regulatory agencies, establishes departmental objectives, drives employee engagement, aligns with other departments, and delivers on site objectives while implementing harmonized engineering systems and processes.

The Manager of Validation will lead a team and ensure that all processes, equipment, facilities, and utilities are appropriately qualified for use, serving as the technical oversight for the facility validation program in accordance with cGMP requirements.

• The Manager of Validation's primary responsibility is to oversee the process for transitioning equipment, computer systems and utilities from Engineering to the end user and ensuring this process meets all required cGMP regulations.
• Continuously monitor and improve the overall health of the Validation Program to ensure continued compliance.
• Work closely with all departments and the Quality Department to ensure the Site is continuously operating in a state of compliance with all cGMP regulations.
• Manage the creation of Validation Protocols for computer systems, critical utilities, and equipment.
• Schedule, plan, and review validation activities.
• Oversee the Validation Master Plan, ensuring timely execution and audit readiness.
• Provide technical expertise and guidance for risk assessments, change control, and validation documentation.
• Partner with cross‑functional teams to support equipment, utilities, facilities and computer validation.
• Provide technical oversight for equipment, facilities, and utilities qualifications and requalifications.
• Build and improve the culture of the Validation team and the site.
• Identify and qualify all computer systems that impact cGMP operations using a risk‑based methodology.
• Develop validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, delivering them within the scope of the validation plan.
• Ensure initiation, preparation and closeout of all related deviations, discrepancies and change‑control documents.
• Conduct or facilitate validation and 21 CFR Part 11 training.
• Adhere to all Biovire policies, including Quality, Human Resources, Health and Safety, to ensure a robust manufacturing environment.

• Strong work ethic and ability to accomplish tasks without supervision.
• Demonstrates leadership by words and by leading by example to foster Biovire culture.
• Strong organizational skills and ability to focus on multiple projects in a fast‑paced work environment.
• Excellent interpersonal skills with the ability to communicate effectively in high‑pressure situations.
• Computer skills (proficient in Microsoft Office applications).
• Possess honesty and integrity with a commitment to the highest legal and ethical standards.
• Treat every person with courtesy and respect.
• Effective delegation and building confidence and competence within direct reports.

• Ability to read and interpret architectural, mechanical, electrical and process drawings and documents.
• Bachelor's degree in a science, engineering or computer subject as a minimum.
• A minimum of 5 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 2 years in a leadership role.
• Hands‑on experience leading and managing validation projects.
• Strong knowledge of manufacturing processes, process equipment and applied statistics.
• Proven ability to write and review technical reports and validation documentation; present information.
• Knowledge of pharmaceutical equipment such as autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage and distribution, RODI water system, and temperature‑controlled units (e.g., refrigerators, freezers and incubators) is an advantage.
• Excellent understanding and experience with industry regulations, standards and guidelines (e.g., GxP, validation, 21 CFR Part 11).
• Excellent interpersonal, communication, organizational and project management skills.
• Supervisory/leadership experience preferred.