Process Engineer Senior, Drug Product Tech Transfer (JP13213)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Process Engineer Senior, Drug Product Tech Transfer
(JP13213) Location: Thousand Oaks, CA. 91320 (Hybrid) Business
Unit: Commercial Drug Product Employment Type: Contract Duration: 1
years with possible extension or conversion to FTE Rate : $44 -
$50/Hours W2 with benefits Posting Date: 09/30/2024 Notes: On site
minimum 3 days per week. 3 Key Consulting is hiring! We are
recruiting a Senior Engineer for a consulting engagement with our
direct client, a leading global biotechnology company. Technical
Skills : Drug product fill finish processing, Holistic DP process
knowledge. Technical transfer, drug product manufacturing,
regulatory filings. Job Description: The Sr Engineer will drive
excellence and innovation in both large and small molecule drug
product manufacturing at. As a key player in our global Process
Development organization they will be instrumental in ensuring the
highest standards of process performance, while also leading the
charge in innovative process improvement strategies. Acts as a drug
product process development technical expert to provide swift and
innovative solutions to complex challenges in formulation,
filtration, filling (vials/syringes/devices) and lyophilization of
parenteral products. Develops and characterizes drug product
processes and transfers new technologies to commercial sterile
fill/finish sites. Provides process development expertise for
commercial drug product processing in specific areas such as
Sterile processing, Process Characterization, Tech Transfer and
Validation. Support commercial drug product manufacturing
operations with technical evaluation of NC/CAPA and technology
transfer. Interfaces with manufacturing as well as all support
functions to provide robust and coordinated support to
manufacturing. Leads and participates in global cross-functional
teams working effectively in a highly matrixed team environment to
influence and drive change, efficiency, and foster strong
relationships. Troubleshoots issues with drug product processing
technologies and equipment. Champions use of data-driven analyses
and visualizations. Investigates to determine true root cause.
Authors and reviews guideline documents, technical protocols,
reports, product impact assessments and regulatory submissions
Identifies and implements operational opportunities for current and
new sterile operations. Preferred Qualifications Advanced degree in
Chemical/Biomedical Engineering, Pharmaceutical Sciences,
Chemistry/Biochemistry or Biotechnology or related field 10 years
of drug product process development experience in the
pharmaceuticals/biotechnology industry Knowledge of/hands-on
experience with end-to-end development for liquid and lyophilized
drug products in various presentations Experience with unit
operation for parenteral manufacturing (i.e. filling, filtration,
mixing, etc.), specifically lyophilization would be an advantage.
Strong skills in applying fundamental engineering and scientific
principles to the design and implementation of protein
freeze-thawing, filtration, mixing, filling and/or lyophilisation
processes. Knowledge of protein biochemistry with regard to
chemical and physical stability. Project management skills
including the ability to manage multiple projects and evaluate
project resource requirements. Strong knowledge of Quality systems,
Drug Product Manufacturing and Validation. Demonstrated ability in
providing leadership to cross-functional teams to advance complex
projects to completion. Excellent communication skills are
essential for this role, as well as a demonstrated proficiency with
the principles of Technical Writing. Top Must Have Skill Sets:
Specifically looking for downstream 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: Create and update manufacturing process
documents, work with cross functional teams on product specific
investigations, complete laboratory investigations and perform
routine testing, monitor process data, imitate and lead meetings
related to product initiatives Basic Qualifications: Doctorate
degree OR Master degree and 3 years of experience OR Bachelor
degree and 5 years of experience OR Associate degree and 10 years
of experience OR High school diploma / GED and 12 years of
experience Why is the Position Open? Supplement additional workload
on team. Red Flags: No experience or short tenures with other jobs.
No experience owning and taking on projects. Not able to come
onsite 3 days onsite. Interview Process: Phone/ Webex, 2-3 rounds
of interviews. 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, Torrance , Process Engineer Senior, Drug Product Tech Transfer (JP13213), Science, Research & Development , Thousand Oaks, California
