Apply to Associate Engineer, Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416)

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.
Master’s 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 1–2 years’ experience; internships valuable).
Bachelor’s 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)

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.