- Developing and implementing state-of-the-art validation solutions for production of vaccine products in company’s Vaccine Business Division (VBD) portfolio.
- Setting global standards for the validation of equipment, facilities, and processes to drive consistency across Operations within the Global VBD Manufacturing Network.
- Partnering with Development Teams and Site Operations & Engineering Teams to generate and execute process / product technology transfers and the associated qualification/validation activities to meet strategic growth initiatives.
- Utilizing external networks to identify resources and build partnerships in the areas of validation technologies to drive best in class manufacturing operations.
- Providing validation technical leadership for the design, construction, start-up and qualification of new vaccine manufacturing facilities / processes.
- Authoring standards for the validation of equipment, facilities, and processes to drive consistency and ensure compliance for production of products in the VBD portfolio.
- Partnering with internal business partners to provide validation input for process fit assessments within existing manufacturing facilities and to define validation requirements for new manufacturing facilities.
- Supporting the development of planning and execution for validation activities for associated with the transfer of products from development into commercial manufacturing and commercial site transfers as required to meet global demand forecasts.
- Providing ongoing technical support for deviation investigations and CAPA management as required during development and commercial manufacturing of products in VBD’s portfolio.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MS or PhD and a minimum of 7 years experience, or BS with a minimum of 10 years experience in cGMP validation for commercial bulk and sterile process operations in vaccines or biopharmaceuticals.
- The Principal Validation Engineer will be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of commercial vaccine manufacturing.
- Demonstrated experience / technical knowledge with drug substance manufacturing, product formulation, aseptic filling, CIP/SIP and isolator technology is required. Lyophilization, extractables/leachables assessments and shipping validation experience is highly preferred.
- Demonstrated experience qualifying drug substance and aseptic drug product manufacturing operations to meet global regulatory requirements is required.
- Direct interaction / experience with regulatory agencies during inspections for licensing of commercial manufacturing operations is a plus.
- Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment.
- Able to lead and manage technical teams, serve as a partner and influence others.
- Travel requirements: 30-40%