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Senior Process Engineer, Upstream or Downstream

2 months ago


Fremont, California, United States LanceSoft Full time
Job Summary

LanceSoft is seeking a highly skilled Senior Process Engineer to join our team in Fremont, CA. As a key member of our process engineering team, you will be responsible for designing, developing, and implementing processes for medium to high complexity projects in our large-scale bio-pharmaceutical manufacturing facility.

Key Responsibilities
  • Develop and implement process designs for medium to high complexity projects, ensuring compliance with GMP regulations and company policies.
  • Collaborate with cross-functional teams to identify and implement process improvements, driving efficiency and quality in our manufacturing operations.
  • Provide technical leadership and guidance to junior team members, ensuring the successful execution of process transfers, launches, and initial supply.
  • Develop and maintain technical documentation, including process descriptions, bill of materials, and campaign performance summaries.
  • Contribute to the design and planning of small-scale studies, collaborating with Process Sciences to transfer or improve at-scale manufacturing processes.
Requirements
  • Bachelor's Degree in Biochemical Engineering or related field, with 6+ years of professional experience or 10+ years of equivalent technical/design experience in large-scale bio-pharmaceutical manufacturing.
  • Strong understanding of fundamental engineering and mathematical concepts, including cell culture, fluid transfer, gas transfer, and mixing.
  • Excellent mechanical aptitude and ability to work in a team setting, with strong communication and project management skills.
  • Ability to work in a hybrid remote/on-site environment and support a 24/7 GMP production facility.
Preferred Qualifications
  • Experience with biopharmaceutical manufacturing processes, project management, and technical writing.
  • Knowledge of aseptic processing, benchtop in-process analytics, buffer preparation, and storage for at-scale GMP manufacturing.
  • Experience with technical writing and BLA filing.