This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.
Responsibilities/Skills:
- Participate in project teams involved on site biotech facilities, processes and equipment for the manufacturer of Drug Substance and/or Drug Product Vaccines
- Review and approve validation related studies for assigned areas
- Validation, Equipment and Facility Qualification and Validation Risk Management.
- Working knowledge of cGMPs and regulatory requirements
- Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processes
- Knowledge of vaccines/biologics products and associated technologies
- Ability to work on cross functional project teams
- Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
Education/Experience:
- 5+ years experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.
- Strong Commissioning and Qualification background