Process EngineerLocation Novato, California
BioMarin’s 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 engineers, technicians, scientists and support staff build and maintain BioMarin’s 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. Come join our team and make a meaningful impact on patients’ lives.
The MSAT downstream process engineer role supports cGMP manufacturing operations by leveraging technical, scientific, engineering, and process expertise. This includes manufacturing support, troubleshooting, continuous process improvement, and assessment/report writing.
Provide technical support related to downstream manufacturing operations, which may include monitoring process performance, troubleshooting GMP equipment/facilities, and providing technical input for manufacturing documents
Provide investigation and generate written assessments to support manufacturing process deviations
Analyze process trends to determine the stability of the manufacturing process
Evaluate and identify areas for improvement in process, utility, or equipment design
Support validation efforts and ensure good engineering principles are applied to all design and implementation activities
Serve as a point person representing MSAT for downstream process-specific issues. When necessary, appropriate judgement is required for escalation or delegation of manufacturing issues to appropriate subject matter experts for resolution
Work collaboratively with Manufacturing, Quality Assurance, Validation, Process Sciences, and Quality Control
B.S. or M.S. in Chemical Engineering or other engineering discipline
3-8 years of relevant industry experience
Demonstrated ability to analyze and synthesize complex problems both verbally and in writing
Demonstrated understanding of downstream processing techniques and unit operations
Knowledgeable in the operation and analysis of downstream systems at various scales
Knowledgeable in cGMP and large-scale manufacturing equipment and practices
Familiarity of regulatory expectations and best practices-------------
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.