Associate Process Engineer
105 Digital Drive Novato, CA 94949 US
Manufacturing Sciences & Technology (MSAT) Frontline staff are technical and process stewards of commercial cGMP Manufacturing across multiple production platforms. MSAT Frontline staff are accountable for investigations and resolution of process-related deviations investigations. The team manages performance monitoring and process knowledge at the Novato site. Our Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain our cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Ability to apply technical knowledge of biopharmaceutical processes (cell culture, purification, etc.) and engineering experience to resolve process issues.
- Support manufacturing process optimization and improvement.
- Skill with performance monitoring tools and their application and interpretation.
- Assist in the incorporation of new technologies, practices and standards into procedures
- Capable of writing and reviewing process and workflow documents, including investigations, campaign technical reviews, APRs.
- QUALITY AND COMPLIANCE:
- Understanding of cGMPs as related to Clinical and Commercial Operations.
- Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
- Ability to participate on projects and contribute to outcomes.
- Collaborate cross-functionally to meet the goal of planned and predictable delivery of product to patients
- Other duties as assigned
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