Mechanical / Biomedical Engineer – Combination Products Test Methods & Validation (GMP, Gage R&R, Auto-Injectors) - (JP15464)

3 Key Consulting•Thousand Oaks, CA

6d•Hybrid

About The Position

This position supports the Combination Product Operations MS&T – Physical Sciences & Engineering (PSE) organization and involves assisting senior engineers with the initiation, design, execution, and delivery of engineering projects. Responsibilities include the development, validation, and lifecycle management of GMP physical test methods, integrated testing equipment, and test methods for auto-injectors and primary containers. The engineer will gather user requirements, develop technical documentation, perform engineering studies, assess automated testing systems, conduct field evaluations of existing equipment, and provide engineering recommendations to support project objectives and continuous improvement initiatives. The ideal candidate has a passion for analytics, modeling, and technology, with the ability to organize information from multiple sources and transform it into well-structured deliverables. This role offers opportunities to apply engineering and data-driven approaches to improve decision-making, optimize testing processes, and support innovation within a highly regulated environment. The position is based at client's Thousand Oaks campus and follows a hybrid schedule, typically requiring two days onsite and three days remote per week, with flexibility based on project and business needs. Standard working hours are Monday through Friday, 8:00 AM to 5:00 PM Pacific Time.

Requirements

Bachelor's degree and 1–3 years of industry experience, preferably within the pharmaceutical, medical device, or biomedical sectors.
Hands-on experience with statistical analysis, Gauge R&R studies, and optical measurement systems.
Working knowledge of CAD/SolidWorks for basic mechanical designs and test fixtures.
Strong technical writing skills.
Familiarity with GMP documentation practices.
Motivated self-starter who enjoys solving technical challenges, learning new technologies, and working effectively both independently and within cross-functional teams.
Passion for analytics, modeling, and technology.
Ability to organize information from multiple sources and transform it into well-structured deliverables.
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.
Experience working in a regulated industry, exposure to GMPs.
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 on Equipment and Method validation principles, equipment characterization protocols, Gauge Repeatability and Reproducibility studies.
Knowledge of force testers.
Test method development.
CAD design.
Solid works.
Mechanical modeling.
Manufacturing experience.

Nice To Haves

Candidates local or open to relocating to Thousand Oaks are welcomed.
Experience with MS Project, Smartsheet.

Responsibilities

Assist senior engineers with the initiation, design, execution, and delivery of engineering projects.
Develop, validate, and manage GMP physical test methods, integrated testing equipment, and test methods for auto-injectors and primary containers.
Gather user requirements and develop technical documentation.
Perform engineering studies and assess automated testing systems.
Conduct field evaluations of existing equipment.
Provide engineering recommendations to support project objectives and continuous improvement initiatives.
Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Assist Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Develop, enhance, automate, and manage test data.
Network with manufacturing and quality organizations internal to client.
Ensure all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs.
Monitor technological developments in the field & evaluation of new technologies.
Led the development of reference samples and test fixtures from concept to fabrication.