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Genentech Process Engineer/Manufacturing in South San Francisco, California,
Process Engineer/Manufacturing
South San Francisco, California
<div class="block-grid"> <div class="block-grid__cell"> <p>Job ID: <a class="link-text link-text--inline" title="Short Link for Process Engineer/Manufacturing" href="http://jobs.gene.com/202011-129176">202011-129176</a></p> <a class="link-text" target="_blank" href="https://www.gene.com/careers/detail/202011-129176/Process-Engineer-Manufacturing/pdf"> <svg><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="#icon-paper"></use></svg>Download PDF </a> </div> <div class="block-grid__cell"> <div class="button__container button__container--bottom button__container--right"> <a href="https://www.gene.com/careers/find-a-job/apply/202011-129176" class="jobapplybutton button" >Apply For This Job</a> </div> </div> </div> <hr> <a class="link-text" href="https://www.gene.com/careers/find-a-job"> <svg><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="#icon-arrow-left"></use></svg>Return to Search Results </a> <h2>The Position</h2> <p> <!DOCTYPE html>Genentech’s South San Francisco manufacturing facility has an opportunity available in the Process Engineering group supporting cGMP manufacturing of both clinical and commercial products. The group is responsible for monitoring, troubleshooting, and improving upstream and downstream unit operations from seed train through bulk formulation, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.
Responsibilities of this position include:
Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
Provide manufacturing floor technical support
Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment
Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
Support product impact and root cause assessments for process discrepancies and Quality investigations
Support of regulatory inspections and filings
Create / revise standard operating procedures and manufacturing tickets
Provide training and technical mentorship for manufacturing operators
Lead cross-functional technical teams on large scale improvement and compliance related initiatives
We are seeking applicants who possess the following minimum qualifications. The position can be filled as an Engineer or Manufacturing Technical Specialist (MTS). The job family and level of the position will depend on the qualifications of the selected candidate.
Bachelor’s degree in Engineering, Science, or related discipline
2+ years of relevant experience in industry or academia (including advanced studies); candidates with more extensive experience may be considered for a senior level.
Experience working in a cGMP environment
Experience with cell culture and/or purification process science/development strongly preferred
Knowledge of safety principles, quality systems, and cGMP
Knowledge of large scale biopharmaceutical manufacturing processes and equipment
Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
Highly motivated and proactive with a track record of taking initiative to achieve business results
Demonstrated strong problem solving capabilities
Able to work independently and as part of a team
Strong oral and written communication skills
Excellent organization skills