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Engineer - Biotech Process Engineering (JP7257)

Thousand Oaks, California · Biotech/Pharmaceutical
Job Title:  Engineer - Biotech Process Engineering (JP7257)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Process Engineering
Duration: 12 months with likely extensions
Job posting date: 4/26/20
3Key Consulting Inc. is hiring an Engineer with process Engineering experience related to chemical, biochemical engineering and/or biochemistry.
Ideal Candidate must have:
  • Biologics cell culture experience must have. Please highlight this in the body of your resume
  • Strong data analytical skills
  • Aptitude for quality and compliance
Job Description:
Seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Thousand Oaks facilities. 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 a new innovative manufacturing suite using single use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic single-use manufacturing facility.
Job Responsibilities:
Under guidance of senior staff, the associate engineer performs the following:
  • Transfers cell culture drug substance processes and performs process improvements from the laboratory into the manufacturing facility
  • Provides technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
  • Offers process validation support for late stage commercial processes
  • Provides routine process monitoring and troubleshooting
  • Executes data trending and statistical process analysis
  • Supports technical direction for process related deviations (NCs), CAPAs and change controls
  • Identifies and supports process related operational excellence opportunities
  • Represents process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

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
  • Upstream 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 OR
    • 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

Top Must-Have Skill Sets:
  • Biologics cell culture experience must have. To be highlight in the body of the resume
  • Strong data analytical skills
  • Aptitude for quality and compliance 
Day to Day Responsibilities
  • Successfully meet day to day deliverables, such as technical assessments in support of production issues and improvements.
  • Provide in-depth real time process development support of a clinical/commercial manufacturing plant.
Employee Value Proposition:
Company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Red Flags:
someone without biologics cell culture experience

Interview process: 
Phone screen followed by Skype interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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