Experience in pharmaceutical/biopharmaceutical industry. Experience in cGMP environment, including commissioning, qualification and validation. Well-developed communication skills, both verbal and written. Should have demonstrated experience collaborating cross-functionally with internal staff, review of design drawing for approval, understanding of the infrastructure required for the construction of a Cell & Gene Therapy facility, overseeing engineering and construction activities, and preparing turnover documentation and as-built drawings. Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Leadership skills. Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.) Lead and manage all aspects of assigned complex projects that support improvements to the facility operations.
- Bachelor’s Degree with experience in a Pharmaceutical Industry and related
- regulatory, engineering, and construction techniques.
- Experience working in cGMP biotech environment and with GDP Practices.
- Cell & Gene Therapy experience is preferred, but not a requirement.