Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 7, 2026
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Job Description:
Job Title: Drug Product Visual Inspection Process Development
Engineer (Aseptic Fill/Finish) - (JP15200) Location: Thousand Oaks,
CA. 91320 Employment Type: Contract Business Unit: Commercial Drug
Product Duration: 1 year with likely extensions and/or conversion
to permanent Posting Date: 04/3/2026 Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. 3 Key Consulting is
hiring an Engineer, Drug Product Process Development & Technology
Transfer for a consulting engagement with our direct client, a
leading global biopharmaceutical company. Top Must Have Skills: 1)
Experience with Visual Inspections 2) Defect Standard Creations 3)
Biosafety Lab Aseptic Technique Job Description: Position involves
support of senior staff in the initiation, design, and delivery of
projects, particularly for automation related scope. Employ basic
engineering skills and practices to gather user requirements and
translate them into technical documentation for execution by third
party firms. Assist with project definition by performing
engineering studies and assessment for automation system
installations. Perform field evaluations of existing systems and
provide engineering design recommendations.; Skills : previous
intern experience is a plus? experience with automation is a plus,
as well as experience with computer programming, systems, and/or
robotics. As a member of the process development team, this role
will be focused on identifying and developing aspects of drug
product to advance process design for parenteral drug products. The
candidate will perform experiments, organize data and analyze
results with minimal supervision. The candidate will establish the
experimental design, develop and implement protocols, obtain
reproducible and reliable results, analyze data and communicate
results to cross functional groups. Key responsibilities include:
Supports ongoing development in the area of visual inspection (i.e.
development and maintenance of defect standards and panels,
establishment of GMP procedures related to operations) Supports the
establishment of robust tactical and strategic objectives related
to visual inspection Implements and documents off-line and on-site
drug product characterization studies Participate in
cross-functional teams working effectively in a highly matrixed
team environment to drive change, efficiency, and strong
relationships Support one or more clinical and commercial process
introductions or process transfers into company manufacturing
network Preferred Qualifications 3 years of experience within the
pharmaceutical/biotechnology industry Experience in
development/characterization of drug product unit operations,
especially visual inspections Understanding of process related
stresses that impact the quality and stability of biologics
Fill/finish process scale-up and technology transfer experience
including the use of gap analysis, root cause analysis, and risk
assessment tools (e.g. Fish bone diagrams, FMEA, etc.) Ability to
use engineering principles to leverage bench and pilot scale models
for process performance characterization Familiarity with cGMPs,
regulatory filings, and compliance issues for sterile injectable
products manufactured by aseptic processing Experience in a matrix
team environment and interacting with Analytical Sciences, Process
Development, Project Management, Manufacturing, Regulatory,
Compliance, and/or Quality Organizational, technical problem
solving, communication (written and verbal) skills, and regular
interactions Ability to learn and act on dynamic information at a
rapid pace Familiar or ability to learn to use electronic record
keeping, GMP, laboratory notebooks, statistical analysis and
software. Laboratory or pilot plant experience with process
equipment Why is the Position Open? Supplement additional workload
on team Day to Day Responsibilities: Supports ongoing hands-on
lab-based development in visual inspection process development
(i.e. development and maintenance of defect standards and panels,
establishment of GMP procedures related to operations) Implements
and documents off-line and on-site drug product characterization
studies Author and/or own high-quality process technology transfer
and other technical documents. 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 Red Flags: No Lab Experience Not good with hands-on
work. Interview process: 2 Phone interviews. 1st 30 minutes with
hiring manager 2nd 30 minutes with team 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, Huntington Beach , Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200), Science, Research & Development , Thousand Oaks, California
