The Mfg. Sciences Purification (MS Pur) group is dedicated to providing scientific and technical support to Vacaville drug substance manufacturing operations, from harvest through formulation and storage. The MS Pur group works in collaboration with Manufacturing, Process Development, Quality, and other technical and business functions in order to ensure efficient and safe drug substance manufacturing processes for the production of multiple recombinant proteins. MS Pur is responsible for process monitoring and analysis, receiving new processes from Process Development or other manufacturing sites, process performance troubleshooting, maintenance of the process validated state and ongoing process improvement. MS Pur pursues scientific excellence and employee development in achieving its goals.
The open position is for a Process Engineer with responsibility for monitoring and analyzing manufacturing process data, maintenance of the process validated state and the configuration of systems for process data acquisition and analysis, enabling the efficient transfer/stewardship of manufacturing processes
Specific responsibilities for this position will include (but are not limited to):
Site Technical steward of the purification process, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the process validated state. Contribute to the design, development, maintenance and improvement of non-GMP tools used by process stewards to support process monitoring and data analysis (in both scale down laboratory and manufacturing scale operations) Author documents and assemble technical information to support process transfer and ongoing manufacturing. Under the guidance of more senior staff, provide technical support for investigations, product impact assessments, inspections, corrective action/preventive action and other quality commitments. Participate in new technology evaluation. Contribute to the supporting data necessary for change implementation. Interact with planning and manufacturing groups to execute process improvement projects Contribute to network teams dedicated to process stewardship, purification process validation and unit operation best practices.
In addition to core responsibilities, the successful candidate may be asked to perform additional technical assignments.
BS or higher degree in Chemical Engineering, Biochemical Engineering, Data Science, Computer Engineering or Computer Sciences
Minimum of 2 years work experience in current good manufacturing practice biopharmaceutical production setting (process development and/or manufacturing technical support).
Working knowledge of manufacturing scale recombinant protein purification operations (e.g. chromatography, ultrafiltration and diafiltration)
Knowledge of GMP documentation requirements
Proficiency in statistical process control and data analysis techniques
Experience with digital/data science tools and programming languages especially in the context of biopharmaceutical applications is considered a strong plus
Self-motivated, able to work independently as well as in teams. Excellent organization and communication skills (both written and verbal)
Ability to support international meetings within the Roche network (early morning / late evening)
The ideal candidate will have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals. They will have a keen interest in learning bioprocess purification operations. Demonstrated proficiency in data analysis techniques and a willingness to learn new techniques is desired. Knowledge in one or more of following software platforms is also preferred: R, Python, SAS JMP, Oracle server and client tools, OSIsoft PI, Visual Basic, data visualization tools (Tableau, Spotfire).
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page . Job Facts JOB FUNCTION
Production Engineering COMPANY/DIVISION
Full time JOB TYPE