Manufacturing Engineer

4 weeks ago

Hillsboro, United States Genentech Full time

Job Summary:

Genentech is seeking a highly skilled Manufacturing Engineer to support the development and production of innovative cell and gene therapies. As a key member of our Manufacturing team, you will play a crucial role in establishing manufacturing processes, controls, and procedures for new technologies.

Key Responsibilities:

  • Support technology transfers and production of cell and gene therapies
  • Collaborate with various teams to establish manufacturing processes and controls
  • Onboard new equipment and processes in collaboration with MSAT and compliance teams
  • Lead the development of batch-related documentation, including manufacturing batch records, SOPs, and training materials
  • Collaborate with compliance and quality members to assess process risks and establish controls for product safety and efficacy
  • Lead end-to-end manufacturing operations for clinical and/or commercial products
  • Drive process improvements and efficiencies using LEAN methodologies

Requirements:

  • Bachelor's degree in a relevant field, such as cellular or molecular biology or engineering
  • 2 years of relevant cell and/or gene therapy industry experience
  • Experience authoring GMP documents, such as SOPs and batch records
  • Experience working in a commercial or clinical GMP environment
  • Experience supporting root cause analysis and developing corrective actions

Preferred Qualifications:

  • Experience driving continuous improvement using LEAN methodologies
  • Experience with data analysis software, ERP systems, and quality management systems
  • Experience as a trainer or team lead
  • Benchwork/lab work experience

About Genentech:

Genentech is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.

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