Mechanical​/Biomedical Engineer – Combination Products Test Methods & Validation; GMP, Gage R

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

Location: Thousand Oaks, CA. 91320 (Hybrid)

Employment Type: Contract

Business Unit: Physical Testing Systems Development

Duration: 18+ months (with likely extensions and/or conversion to permanent)

Posting Date: 06/16/26

Pay Rate: $42 - $46/hour W2

Notes: Only qualified candidates need apply. Candidates local or open to relocating to Thousand Oaks are welcomed. Hybrid.

3 Key Consulting is hiring a Mechanical / Biomedical Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

The ideal candidate is a Mechanical or Biomedical Engineer with a Bachelor's degree and 1–3 years of industry experience, preferably within the pharmaceutical, medical device, or biomedical sectors. Candidates should possess hands‑on experience with statistical analysis, Gauge R&R studies, and optical measurement systems, along with a working knowledge of CAD/Solid Works for basic mechanical designs and test fixtures. Strong technical writing skills and familiarity with GMP documentation practices are essential.

The successful candidate will be a motivated self‑starter who enjoys solving technical challenges, learning new technologies, and working effectively both independently and within cross‑functional teams.

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 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 the 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.

• 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

• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
• Knowledge on equipment and method validation principles, equipment characterization protocols, Gauge Repeatability and Reproducibility studies.
• Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
• Developing, enhancing, automating, and managing test data.
• Network with manufacturing and quality organizations internal to client.
• Ensuring all tasks and responsibilities are performed according to industry‑leading scientific standards & accurately documented per SOPs.
• Monitoring technological developments in the field & evaluation of new technologies; led the development of reference samples and test fixtures from concept to fabrication.

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 of force testers
• Test method development, CAD design, Solid Works, mechanical modeling
• Manufacturing experience

• Passion for proactively identifying opportunities through creative data analysis and modeling
• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
• Ability to manage multiple, competing priorities simultaneously, experience with MS Project, Smartsheet

• Not willing to commute to work (minimum twice a week)
• Overqualified candidates (6+ years Pharmaceutical experience)
• No Engineering experience
• Job hopping (6 months or less at each place)