Drug Product Process Engineer I/II

South San Francisco
California, United States of America


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The Position

Engineers and Manufacturing Technical Specialists in the Drug Product Process Engineering (DPPE) department provide technical support to commercial and clinical drug product operations including bulk preparation, aseptic filling, lyophilization, visual inspection, and packaging at Genentech's South San Francisco manufacturing site. In this position, you will need to work effectively as part of a team responsible for ensuring successful and efficient Drug Product Filling and Inspection Operations that occur at the site. Specifically, to ensure that production demands are satisfied and drug products are delivered in a safe, high quality, cGMP compliant, reliable and cost effective manner.

Responsibilities

  • Responsible for the technical success of the clinical and commercial drug product operations (freeze-thaw through to final package) including tactical, project and product/process support
  • Monitor and analyze manufacturing data as necessary to optimize drug product operations, and in support of discrepancy/ investigation management, equipment troubleshooting, CAPA, and regulatory inspections and filings
  • Lead and support equipment and process troubleshooting efforts which may include on-call or off-hours support
  • Implement engineering projects for tech transfers, improving success rates, reducing recurring discrepancies, increasing capacity/productivity, and increasing levels of safety and compliance
  • Design and execute studies aimed at improving process and equipment robustness/productivity or meeting the changing needs of the manufacturing environment
  • Collaborate closely with Operations, Quality, Facilities, Regulatory, Process Development, Supply Chain, and other key groups involved in cGMP manufacturing to ensure and maintain compliance with company and cGMP standards
  • Provide training and technical mentoring to drug product operations personnel
  • Apply engineering principles and technical expertise in supporting manufacturing areas
  • Maintain safe manufacturing work environment that complies with company and regulations

Requirements

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to provide employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

  • A B.S. or M.S, in relevant engineering/scientific discipline, or equivalent coursework and experience; typically three to five years of relevant industrial experience supporting GMP biochemical processing
  • Troubleshooting experience and a demonstrated aptitude for mechanical systems
  • Knowledge of safety principles, quality systems, and cGMP
  • Demonstrated ability to be strategic and results driven
  • Works well in a collaborative and high functioning team environment
  • Strong communication skills

* We are recruiting for multiple positions. Only local candidates being considered.

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.

The next step is yours. To apply today, click on the "Apply online" button.

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.


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