Senior Engineer/ Senior Manufacturing Technical Specialist, iNeST (User Team)

Hillsboro
Oregon, United States of America


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The Position

Please note there are three positions available

Main Purpose of the Position:

This position is part of Genentech’s exciting iNeST program.  iNeST (individualized Neoantigen Specific Therapy) program is an RNA-based cancer therapy targeting neoantigens manufactured on a per-patient basis

In this role, you will design, install, test, and validate state-of-the-art manufacturing equipment intended to produce medicine on a per-patient basis.  Additionally, you will write product impact assessments, sampling, plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes and documentation pertaining to process development, qualification, and validation to meet regulatory requirements.

Responsibilities:

  • Provide technical support and training to Operations and Maintenance
  • Build reliability into Operations equipment and processes
  • Establish equipment failure and risk analysis processes to increase reliability
  • Provide frontline troubleshooting and issue resolution support for the packaging operations to decrease time of recovery from equipment malfunctions
  • Support product & component introductions
  • Identify and implement batch & yield improvements
  • Identify and implement process & safety improvements
  • Drive FMEA to improve the quality and reliability of design
  • Support Investigations and atypical events, as well as resulting corrective or preventive action implementation
  • Root cause analysis facilitation/participation
  • Development and execution of integrated, startup, and qualification (IQ/OQ/PQ) activities
  • Training program development; Participate in FAT efforts at vendor sites
  • Identify, evaluate, and implement new process technologies in alignment with business objectives or regulatory requirements

Qualifications / Requirements:

  • B.S. degree engineering or related field
  • Possess a minimum of 8 years of experience in the Pharmaceutical Field
  • Experience with cell therapy manufacturing is preferred
  • Knowledge of filling and related equipment and processes is preferred
  • Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
  • Excellent communication skills are a must
  • Ability to assess and develop timely, effective solutions for manufacturing equipment and processes is key
  • Six Sigma Green or Black Belts is a plus

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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