Engineer, Biotech - Processing & Manufacturing (JP10528)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Biotech Processing & Manufacturing
(JP10528) Location: Thousand Oaks, CA. (Hybrid - 50% onsite)
Employment Type: Contract to Hire Business Unit: C ommercial Drug
Product Duration: 1 year with likely extension of conversion to FTE
Posting Date: 7/7/2022 3 Key Consulting is hiring an Engineer for a
consulting engagement with our direct client, a leading global
biopharmaceutical company. Job Description: 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. Specific responsibilities include but are not limited to:
Design, execute and document primary data packages related to drug
product design and process development, and communicate key
findings in presentations Develop solutions to technical problems
during process characterization and aseptic manufacturing Support
one or more clinical and commercial process introductions or
process transfers into company manufacturing network Author and
review technical protocols, reports, product impact assessments,
and regulatory sections in support of IND and marketing application
submissions Provide ongoing support to clinical and commercial
fill/finish manufacturing operations through troubleshooting, root
cause analysis, and product impact assessments for non-conformance
investigations and process changes/improvements Participate in
cross-functional teams working effectively in a highly matrixed
team environment to drive change, efficiency, and strong
relationships Preferred Qualifications MS in Chemical/Biomedical
Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or
Biotechnology 3 years of experience within the
pharmaceutical/biotechnology industry Experience in
development/characterization of aseptic fill/finish unit operations
(freeze/thaw, mixing, sterile filtration, filling, stoppering,
visual inspection, etc.) to define critical process parameters
Aseptic fill finish manufacturing or manufacturing technical
services experience including the development of control strategies
and active process performance monitoring Understanding of process
related stresses that impact the quality and stability of biologics
Ability to use engineering principles to leverage bench and pilot
scale models for process performance characterization 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.) Familiarity with Design of
Experiments (DOE) and Quality by Design (QbD) principles
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 Skills : BS in
Chemical/Biomedical Engineering, Pharmaceutical Sciences,
Chemistry/Biochemistry or Biotechnology with 3 years of experience
within the pharmaceutical/biotechnology industry Why is the
Position Open? Staff Augmentation Top Must-Have Skill Sets:
Experience in drug product filling Laboratory experience Employee
Value Proposition: To work for a dynamic team Interview process:
Phone screen with hiring manager In person or phone interviews with
3-4 team members We invite qualified candidates to send your resume
to recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to look at
the other positions on our website www.3keyconsulting.com/careers.
You are welcome to also share this opportunity with anyone you
think might be interested in applying for this role Regards, 3KC
Talent Acquisition Team
Keywords: 3 Key Consulting, Thousand Oaks , Engineer, Biotech - Processing & Manufacturing (JP10528), Science, Research & Development , Thousand Oaks, California
