Manager of Validation

Biovire•Brighton, MI

About The Position

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 appropriate 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, schedule, coordinate, and perform validation studies, evaluate study results, and potentially propose 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 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. 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:

Requirements

Must have the ability to read and interpret architectural, mechanical, electrical and process drawings and documents
Bachelor's degree in a science/engineering/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.
Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc.
Excellent interpersonal, communication, organizational, and project management skills.
Strong work ethic and ability to accomplish tasks without supervision
Demonstrates leadership both by words and leading by example to foster Biovire culture.
Strong organizational skills and the 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
Treats every person with courtesy and respect
Effective delegation and building confidence and competence within direct reports

Nice To Haves

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.
Supervisory/leadership experience preferred.

Responsibilities

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.
Scheduling, Planning and review of 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.
Provides technical oversight for equipment, facilities, and utilities qualifications and requalifications.
Build & improve the culture of the Validation team and the site
Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
Develop validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables 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 but not limited to Quality, Human Resources, Health and Safety, that will ensure a robust manufacturing environment