Principle Engineer I
770 Lindaro St San Rafael, CA 94901
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- This position will support EHS&S department by assisting with technical investigations to support process hazard assessments, manufacturing procedure assessments, and other assessments to ensure all EHS&S regulatory compliance mandates are met.
- Technical investigations shall include, and not be limited to, biotechnology literature reviews, product specifications assessments and recommendations, review and recommendation of alternate approaches, process hazard analysis (PHA), Failure Modes and Effects Analysis (FMEA), development and delivery of biotechnology training materials, assessment of biosafety principals to ensure compliance with NIH guidelines, provide review and written recommendations on manufacturing designs and specifications, evaluations of existing and newly proposed manufacturing infrastructure and equipment, participate in technical meetings and discussions, and conduct related research assignments as requested by the customer.
- Scientific understanding and technical expertise in Biologics and Viral Vector manufacturing.
- Work product will include technical reports, technical memorandums, presentations, e-mail communications, and other formats to support company-wide communication.
- Position will involve a combination of on-site and off-site work requirements as needed by the customer.
- Weekly hours of support will be variable between 0-40 and as needed by customer; immediate needs will be in the 24-32 hours per week range.
- Process Hazard Analysis (PHA).
- Failure Modes and Effects Analysis (FMEA) BioSafety Principles and Practices (GLSP, BSL1, BSL2, etc) Risk Assessments Biologics GMP Manufacturing Viral Vectors and Gene Therapy Manufactruing Cell Culture and Purification Processes Design Review.
- 10+ years M.Sc. or Ph.D in biochemistry, modelcular biology, biologics or pharmaceutical process engineering.