Process Development Engineer, upstream drug substance (JP13223)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
|
|
|
Job Description:
Job Title: Process Development Engineer, Upstream Drug Substance
(JP13223) Location: Thousand Oaks, CA. 91320 Business Unit: Drug
Product Development Manufacturing Employment Type: Contract
Duration: 1 years with possible extension or conversion to FTE Rate
: $38 - $42 / hr. Posting Date: 9/24/2024 Notes: On site minimum 3
days per week. Specifically looking for upstream experience. 3 Key
Consulting is hiring! We are recruiting an Engineer for a
consulting engagement with our direct client, a leading global
biotechnology 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 cell culture and/or 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. * onsite a minimum of 3
days a week Must have biotech background/experience, plus must have
cell culture and/or purification experience Top Must Have Skill
Sets: Specifically looking for upstream purification experience
Strong communication - must be comfortable speaking to a group of
20 manufacturing associates in presentation (data reviews/etc.) GMP
experience highly preferred (Looking for GMP background/ someone
who has dealt with FDA/ inspectors/ auditors) Day to Day
Responsibilities: 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 collaborate with
other functions such as Manufacturing, Quality, and Regulatory
Basic Qualifications: Master degree OR Bachelor degree and 2 years
of experience OR Associate degree and 6 years of experience OR High
school diploma / GED and 8 years of experience Strong communication
- must be comfortable speaking to a group of 20 manufacturing
associates in presentation (data reviews/etc.) GMP experience
highly preferred (Looking for GMP background/ someone who has dealt
with FDA/ inspectors/ auditors) Why is the Position Open?
Supplement additional workload on team. Interview Process: Phone/
Webex We invite qualified candidates to send your resume to
recruiting@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, Lynwood , Process Development Engineer, upstream drug substance (JP13223), Engineering , Thousand Oaks, California
