Job Title: Associate Engineer Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416) Location: Thousand Oaks CA. 91320 Employment Type: Contract Business Unit: CPO Process Engineering Duration: 2 years (with likely extensions and/or conversion to permanent) Posting Date: 08/29/25 Pay Rate: $32 - $34/hour W2 Notes: Only qualified candidates need apply. 100% On-site thousand oaks - possibility for some remote work after training. Schedule is 8am 5pm no overtime/holiday expectation. This position is on site and might require to travel depending on the project/program needs.
3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: The ideal candidate for this position:
The Associate Engineer will hold a STEM degree in Mechanical Biomedical Biotech or a related field and bring about 1-2 years of internship or professional experience in mechanical design automation process engineering and root cause analysis.
This role requires strong documentation and report-writing skills alongside hands-on lab experience supporting clinical manufacturing and medical device tech transfers (e.g. syringes auto-injectors).
Candidates should be entry-level with the ability to learn and grow during a two-year assignment comfortable investigating deviations and capable of collaborating with engineering and vendor teams with potential for future conversion based on performance.
Masters degree could be considered a plus.
Open to non-traditional candidates if lab/instrument experience is applicable.
In this role the candidate will work cross functionally supporting tech transfer activities for clinical and commercial with client and CMO sites getting exposure to the FDP manufacturing processes for automated and HMLV (high mix low volume) processes for combination products (device assembly labeling and packaging). This includes identifying and exploring technologies in partnership with site PD NPI lead Validation Engineering and Project Management.
Entry-level preferred (fresh grads or 12 years experience; internships valuable).
Bachelors in STEM (Mechanical Engineering Biomedical Engineering Biotech etc.).
Experience in:
Mechanical design automation software process engineering.
Root cause analysis (RCA).
Documentation and report writing (large administrative/documentation component).
Why is the Position Open Supplement additional workload on team
Top Must Have Skills:
Mechanical Design
Automation Software
Process Engineering
Day to Day 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
Basic Qualifications:
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
Employee Value Proposition: Good potential for learning & growth with possible conversion after 2 years.
Red Flags:
Overqualification (too much experience PhD too many certifications risk of attrition).
Non-STEM degrees without relevant lab/engineering exposure.
Frequent job hopping (multiple short stints 6 months).
Generic/AI-generated resumes lacking context.
Unexplained long employment gaps (less critical for entry-level).
Interview process: 1 Phone Screen 1 Panel In Person (or virtual)
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