Thousand Oaks, CA 91320

Posted: 04/11/2024 Job Number: 38976

Job Description


Top 3 Must Have Skill Sets:
  • Must have at-scale biologics cell culture experience (manufacturing experience, engineering experience)
  • Strong understanding of data analysis tools (JMP preferred)
  • Excellent communication and troubleshooting (Must be comfortable presenting data & technical information to a group of 20+ people. Presenting at min once per month to quarter)

Red Flags:
  • Remote work only.
  • Multiple short-term work experience
  • Lack of upstream cell culture experience
  • Cell culture purification only
  • Non science background/degree
  • Not sociable
  • Not good with presenting


Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply cell culture process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

Under guidance of senior staff, the Engineer performs the following:
  • Transfer cell culture processes for drug substance manufacturing and performs process improvements from the laboratory into the manufacturing facility
  • Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
  • Offer process validation support for late stage commercial processes
  • Provide routine process monitoring and troubleshooting
  • Execute data trending and statistical process analysis
  • Support technical direction for process related deviations, CAPAs and change controls
  • Identify and support process related operational excellence opportunities
  • Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

Basic Qualifications:
  • Master’s degree
  • Bachelor’s degree and 2 years of Engineering or Operation experience
  • Associate’s degree and 7 years of Engineering or Operations experience

  • High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:
  • Master’s Degree in Chemical or Biochemical Engineering
  • 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
  • Background in biologics tech transfer into commercial facilities
  • Cell culture process knowledge: Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
  • Strong capability of analysis, troubleshooting and problem solving
  • Ability to develop and follow detailed protocols
  • Independently motivated with ability to multi-task and work in teams
  • Excellent written and verbal communication skills with technical writing and presentation experience


Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.


At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.