Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: Physical Methods Development, Modelling and Emerging Methods Duration: 12+ months with likely extensions and/or conversion to permanent Rate: $36-41/Hr. - W2 with benefits Posting Date: 02/18/2026 Notes: Will be onsite at least 2x/ week
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal Candidate: 2 Years of Experience, hands on engineering, validation and qualifying equipment.
Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.
Skills:
Previous intern experience is a plus
Experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.
Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for CCIT system installations. Perform field evaluations of existing systems and provide engineering design recommendations and support development of CCIT technologies.
Basic Qualification
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
Top Must Have Skills:
Nice to have skills: (manager would like to see but not all skills are a hard requirement)
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership.
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing.
Test method development, CAD design, SolidWorks, mechanical modeling.
Manufacturing experience, IQ, OQ, and PQ.
Day to Day Responsibilities:
Equipment and Method validation principles, generation of Lifecycle
Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies.
Troubleshooting of various lab instruments and automation systems, which will require learning the specific software controlling the instruments and integrated systems from vendor manuals, and site documents.
Red Flags:
No hands on Engineering experiences or credited
Interview process:
2 Rounds for interviews.
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 take a 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.