Engineer I/II – Manufacturing Science and Technology (MSAT)

Job description

  Job facts

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 processrobustness/productivityor 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 increasecapacity/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 for this position who possess the following qualifications. The 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) post Bachelor's degree
·  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
·  Able to work independently and as part of a team
·  Strong oral and written communication skills
·  Excellent organization skills

As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule. Requires the ability to routinely access and work for extended periods of time in a cGMP facility, including adherence to all gowning and safety procedures.

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering

·  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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.