Process Engineer, Biotech Drug Substance Technology (JP10848)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Process Engineer, Biotech Drug Substance Technology
(JP10848) Location: Thousand Oaks, CA. (Local/hybrid) Employment
Type: Contract Business Unit: Process Engineering – Drug Substance
Technology Engineering group. Duration: 1 years (with likely
extensions and/or conversion to permanent) Posting Date: 10/05/22
Notes: Only qualified candidates need apply. Onsite a minimum of 3
days a week. Must have biotech background/experience, plus must
have purification experience 3 Key Consulting is hiring an
Engineer, Drug Substance Technology for a consulting engagement
with our direct client, a leading global biopharmaceutical company.
Job Description: 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 purification
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 purification
drug substance processes 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 Top
Must Have Skills: Strong understanding of data analysis tools
Knowledge of biologics purification processes/ equipment; scale up
factors from, chromatography *1 years of Process Engineering
experience preferably related to scale-up principles and commercial
cGMP manufacturing facilities *Manufacturing experience must be
biotech experience Day to Day Responsibilities: Staff will perform
tech transfer of early clinical candidate molecules. In addition,
staff will support all processes (clinical and commercial) executed
in the facility, performing process monitoring and responding to
issues as appropriate Basic Qualifications: Master’s degree OR
Bachelor’s degree Associate’s degree and 7 years of Engineering or
Operations experience OR 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 Purification
process knowledge: Knowledge of purification processes/ equipment;
scale up factors from, chromatography, UF/DF, 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 Red Flags: Multiple short duration jobs on resume No
purification experience - critical experience (Chromatography,
purification, USTF) Manufacturing experience - must be biotech
experience Interview process: Initial Phone screen by hiring
manager followed by Webex interview by team We invite qualified
candidates to send your resume to resumes@3keyconsulting.com . If
you decide that you’re not interested in pursuing this particular
position, please feel free to take a look at the other positions on
our website www.3keyconsulting.com/careers. You are also welcome to
share this opportunity with anyone you think might be interested in
applying for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Oxnard , Process Engineer, Biotech Drug Substance Technology (JP10848), Engineering , Thousand Oaks, California
