3 Key Consulting, Inc. · 1 month ago
Engineer, Drug Product Development, Process Design & Experimentation - Hybrid (JP14756)
Thousand Oaks, CA
Full-time
Hybrid
Entry, Mid Level
$36/hr - $41/hr
2+ years exp3 Key Consulting, Inc. is hiring an Engineer for Drug Product Development, Process Design & Experimentation for a consulting engagement with a leading global biopharmaceutical company. The role focuses on advancing process design for parenteral drug products, performing experiments, analyzing data, and communicating results to cross-functional teams.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
Supports the establishment of robust tactical and strategic objectives related to visual inspection
Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect 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
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
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
Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
Support one or more clinical and commercial process introductions or process transfers into client manufacturing network
Qualification
Required
B.S. and 2 years of experience in Pharma with drug product experience
Good documentation practices (GDP)
Experience with visual inspection
Technical writing skills
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
Preferred
2+ 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
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
Strong knowledge of quality systems and drug product manufacturing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Capable of organizing and communicating complex technical concepts to enable business decisions
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase