Process Engineer, Biotech Drug Substance Technology (JP11861)
Company: 3 Key Consulting
Location: West Hills
Posted on: April 1, 2026
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Job Description:
Job Title: Process Engineer, Biotech Drug Substance Technology
(JP11861) Location: Thousand Oaks, CA. (Local/hybrid) Employment
Type: Contract Business Unit: Commercial DP - Process Eng Duration:
Initial 9 months with likely extensions and/or conversion to
permanent Posting Date: 10/09/23 Rate : $38-42/HR W2 Notes: Must be
local (1-2 days a week) . Masters Degree is highly preferable,
Pharma industry experience , Independent worker 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: As a member of the
process development team, the candidate will be focused on
supporting senior staff to develop and characterize drug product
technologies and manufacturing capabilities, as well as assist in
the process validation and technology transfer of multiple products
to various aseptic fill finish manufacturing plants and production
lines. The candidate will support senior staff in the planning,
execution and documentation of characterization, process validation
and technology transfer projects. The candidate will be primarily
responsible for executing characterization studies and other
experiments at the lab scale and production scale to generate
technical data packages using complex technology, while organizing
data and analyzing results under supervision of senior staff. The
candidate will be responsible for liaising with various drug
product teams to ensure successful technology transfer, with
associated documentation, of client’s products. The candidate will
assist to establish the experimental design, develop and execute
protocols, obtain reproducible and reliable results, analyze and
document experimental results, and communicate results to cross
functional groups. Basic Qualifications Master’s degree OR
Bachelor's Degree and 2 years of relevant experience . Preferred
Qualifications/Educational background in Chemical Engineering,
Biomedical Engineering, Biotechnology correlated technical field of
study in biotechnology, life sciences or related discipline.
Knowledge in scientific principles of freeze/thaw,
formulation/mixing, filtration, filling, lyophilization, capping,
and visual inspection. Ability to work on multiple projects
simultaneously, learn new techniques, keep accurate records, follow
SOP’s and instructions in compliance with company policies, and
comfortable to operate in a very flexible, agile environment
Ability to independently design and execute characterization
studies, author characterization protocols, process transfer
documents, application notes and technical reports. Proficiency in
technical problem solving, critical thinking, and delivery of
technical solutions with some oversight Strong knowledge of Quality
systems and Drug Product Manufacturing (GMP). Demonstrated ability
to use interpersonal skills to build strong technical
relationships. Self-motivation, adaptability, and a positive
attitude. Excellent communication skills, both oral and written.
Top Must Have Skills: Masters Degree HIGHLY PREFERABLE Familiarity
with cGMP and experience in drug product / drug substance
manufacturing or process development in pharmaceutical industry
setting and manufacturing Knowledge of and hands-on experience with
various drug product technologie s Ideal candidate: Must have at
least a Masters Degree Pharma industry experience Independent worke
r Day to Day Responsibilities: Responsibilities include, but are
not limited to, the following: Apply fundamental engineering and
scientific principles to resolve issues and evaluate effects of
process improvements, equipment, scale, and raw materials Assist in
the design and execution of experiments in order to characterize
and enable implementation of new capabilities and process changes
such as filling, lyophilization and analytical technologies Support
technology transfer leads during the transfer of drug products into
manufacturing sites (clinical and commercial), including
make-a-batch exercises, process transfer documents, and change
control assessments Support development of technology transfer
tools (clinical and commercial) Effectively communicate results of
characterization studies, experimental execution and technology
transfer initiatives Author/review technical documents, such as
technical protocols, technical assessments, technical reports and
draft standard operating procedures Conduct analysis of data
generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data
analytics and programming skill s Red Flags: No pharma experience
Must have experiment experience Not an entry level role Interview
process: Phone screening followed by video call (panel interview)
We invite qualified candidates to send your resume to
recuiting@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, Irvine , Process Engineer, Biotech Drug Substance Technology (JP11861), Science, Research & Development , West Hills, California
