Engineer - (JP10385)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer - (JP10385) Location: Thousand Oaks, CA.
91320 Employment Type: Contract Business Unit: Process Engineering
Duration: 1 years (with likely extensions) Posting Date: 06/02/22
Notes: Only qualified candidates, please. Hybrid position.
Candidate will be required to be on site half the week and may work
remotely 1-2 days a week. Must have biotech background/experience,
plus must have purification experience. 3 Key Consulting is hiring
an Engineer 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
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 Why is the Position Open? Supplement additional workload
on team. Top Must-Have Skill Sets: 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 Red Flags: Multiple short duration jobs on resume No
purification experience - critical experience (Chromatography,
purification, USTF) Manufacturing experience - must be biotech
experience Interview process: Phone screening followed by in-person
interview. 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, Aliso Viejo , Engineer - (JP10385), Engineering , Thousand Oaks, California