3 Key Consulting, Inc. · 4 months ago
Associate Engineer, Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416)
Thousand Oaks, CA., California
Full-time
Onsite
Entry Level
$32/hr - $34/hr
1+ years exp3 Key Consulting, Inc. is hiring an Associate Engineer for a consulting engagement with a leading global biopharmaceutical company. The Associate Engineer will support tech transfer activities for clinical and commercial products while collaborating with engineering and vendor teams, focusing on mechanical design, automation, and process engineering.
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Responsibilities
Support Tech Transfer activities
Lead process gap assessment exercises
Generate PTD (Process Transfer Document)
Manage dashboards by updating KPI status and timelines
Support characterization and PPQ activities at the receiving site
Perform forensic analysis of devices
Conduct root cause analysis using standard methodologies
Leverage automation skillset to access and analyze equipment data
Program within statistical analysis software or data tools such as MATLAB
Update and optimize equipment automation recipes for quality, rapid device assembly
Support design of test fixtures and/or assembly tools for manufacturing
Troubleshoot device and equipment failure
Qualification
Required
The Associate Engineer will hold a STEM degree in Mechanical, Biomedical, Biotech, or a related field
1-2 years of internship or professional experience in mechanical design, automation, process engineering, and root cause analysis
Strong documentation and report-writing skills
Hands-on lab experience supporting clinical manufacturing and medical device tech transfers (e.g., syringes, auto-injectors)
Entry-level with the ability to learn and grow during a two-year assignment
Comfortable investigating deviations
Capable of collaborating with engineering and vendor teams
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Engineering or biotechnology background
Enthusiasm for new technology (digital and mechanical)
Continuous improvement mindset
Clear communication and presentation skills
Preferred
Master's degree could be considered a plus
Open to non-traditional candidates if lab/instrument experience is applicable
Entry-level preferred (fresh grads or 1–2 years' experience; internships valuable)
Experience in Mechanical design, automation, software, process engineering
Experience in Root cause analysis (RCA)
Experience in Documentation and report writing (large administrative/documentation component)
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