Associate Process Engineer
Novato, CA
Who We Are BioMarin\u2019s 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\u2019s 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. THIS IS A HYBRID ROLE (REQUIRED TO BE IN THE OFFICE TWO DAYS A WEEK)ROLEManufacturing 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. BioMarin\u2019s 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 BioMarin\u2019s 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.KEY RESPONSIBILITIESPROCESS KNOWLEDGE: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.SkillsSkill with performance monitoring tools and their application and interpretation.TECHNICAL DOCUMENTATION:Assist in the incorporation of new technologies, practices and standards into proceduresCapable 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.)BUSINESS:Ability to participate on projects and contribute to outcomes.Collaborate cross-functionally to meet the goal of planned and predictable delivery of product to patientsOther duties as assignedEducationBachelor's Degree Required PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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