Manager of Validation

General Description The Manager of Validation leads the Commissioning Qualification and Validation (CQV) and Computer System Validation (CSV) area. Ensures that all equipment, facilities, and utilities are appropriately qualified for use. The Manager serves as the technical oversight for the facility validation program. The individual ensures equipment is appropriately qualified for use and prioritizes assignments and allocates and assigns labor to support them. Provides directions and instruction to both professional staff members and is also responsible for evaluating their work. Writes technical reports, schedules, coordinates, and performs validation studies, evaluates study results, and potentially proposes alternative validation strategies. Participates in audits where extensive contact with clients and members of regulatory agencies is required. Establishes department objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes.

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

Essential Duties and Responsibilities:

1. The Manager of Validations 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.
2. Continuously monitor and improve the overall health of the Validation Program to ensure continued compliance.
3. To 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.
4. Manage the creation of Validation Protocols for computer systems, critical utilities, and equipment.
5. Scheduling, planning, and review of validation activities.
6. Oversee the Validation Master Plan ensuring timely execution and audit readiness.
7. Provide technical expertise and guidance for risk assessments, change control, and validation documentation.
8. Partner with cross-functional teams to support equipment, utilities, facilities, and computer validation.
9. Provides technical oversight for equipment, facilities, and utilities qualifications and requalifications.
10. Build & improve the culture of the Validation team and the site.
11. Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology.
12. Develop validation plans, qualifications, test protocols, traceability matrices, reports, IQ/OQ protocols, and all documents and deliverables within the scope of the validation plan.
13. Ensure initiation, preparation, and closeout of all related deviations, discrepancies, and change control documents.
14. Conduct or facilitate validation and 21 CFR Part 11 training.
15. Adhere to all Biovire policies including but not limited to Quality, Human Resources, Health, and Safety that will ensure a robust manufacturing environment.

Behavioral Expectations

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

WORK EXPERIENCE AND EDUCATION REQUIREMENTS This is a key management role within the Biovire organization; therefore, the expectations and credentials of the candidate are demanding. The educational requirements represent the minimum for this position.

1. Must have the ability to read and interpret architectural, mechanical, electrical, and process drawings and documents.
2. Bachelors degree in a science, engineering, or computer subject as a minimum.
3. 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.
4. Hands-on experience leading and managing validation projects.
5. Strong knowledge of manufacturing processes, process equipment, and applied statistics.
6. Proven ability to write and review technical reports and validation documentation, present information.
7. 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.
8. Excellent understanding and experience with industry regulations, standards, and guidelines (e.g., GxP validation, 21 CFR Part 11, etc.).
9. Excellent interpersonal, communication, organizational, and project management skills.
10. Supervisory/leadership experience preferred.