Process Development Engineer, upstream biologics (JP14405)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Process Development Engineer, upstream biologics
(JP14405) Location: Thousand Oaks, CA. 91320 Employment Type:
Contract Business Unit: PD B23 Mfg Spt Duration: 1 years with
likely extensions and/or conversion to permanent Posting Date:
08/28/2025 Pay Rate: $36 - $41/hour W2 Notes: HYBRID 3/4 days
onsite, 1-2 remote (activities permitting) at Thousand Oaks, CA.
Standard Business hours with some after-hours support (on call for
manufacturing support potentially twice a month for 2-4 hours). 3
Key Consulting is hiring an Engineer for a consulting engagement
with our direct client, a leading global biopharmaceutical company.
Job Description: The ideal candidate will be a Process Development
Engineer with a strong foundation in upstream biologics, including
suspension cell culture, bioreactor operations, and monoclonal
antibody production. The engineer will join the Drug Substance
Technology Engineering team, supporting the development and
manufacturing of human therapeutic products from clinical stages
through commercial production. They will apply process engineering
knowledge to support technology transfer and manufacturing in an
advanced suite utilizing single-use technology. The ideal candidate
will hold a bachelor’s degree in Engineering, Biology, or a related
scientific field with 2 to 5 years of relevant experience, or a
master’s degree with new graduates considered. They should be
proficient in data and statistical analysis tools such as JMP,
possess excellent communication skills, and thrive in
cross-functional collaboration. Comfort working in a regulated,
fast-paced environment and presenting technical data to diverse
teams is essential. Candidates who are remote only, lack upstream
experience, have excessive short-term job history, or come from
non-scientific or non-engineering backgrounds should be avoided.
JOB RESPONSIBILITIES: 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
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 Top Must Have Skills:
Must have at-scale biologics cell culture experience (manufacturing
experience, engineering/equipment 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) 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. GMP experience is a huge plus - someone who has dealt
with regulatory inspectors/auditors (FDA, other regulatory agencies
from other countries) Day to Day Responsibilities: Staff will
support all upstream processes (clinical and commercial) executed
in the facility, performing process monitoring and responding to
issues as appropriate. In addition, staff will perform and/or
support tech transfer of early clinical candidate molecules. Basic
Qualifications: Master’s degree OR Bachelor’s degree and 2 years of
Engineering or Operation experience Associate’s degree and 7 years
of Engineering or Operations experience Red Flags: Remote work
only. Multiple short-term work experiences Lack of upstream cell
culture/harvest experience Purification experience only Non
scientific/engineering background/degree Not sociable Not good with
presenting technical data Interview process: Video interview panel
with team (1:4/6) *Available to interview when the candidate is
identified* 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, Altadena , Process Development Engineer, upstream biologics (JP14405), Engineering , Thousand Oaks, California
