Engineer – Mechanical Design & Test Method Development; JP

Job Title: Engineer – Mechanical Design & Test Method Development (JP14414)

Location: Thousand Oaks, CA. 91320

Employment Type: Contract

Business Unit: Mechanical Design Engineering

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

Posting Date: 09/04/25

Pay Rate: $36 - $41/hour W2

Notes: Only qualified candidates need apply. Thousand Oaks Local Candidates Only. Potential for Hybrid. 18 months with possible 18-month extension based on performance

Overview

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

Job Description:

The ideal candidate is a junior to mid-level Mechanical or Biomedical Engineer (Bachelor’s degree, 1–3 years of experience, Master’s acceptable) with hands-on pharmaceutical or biomedical industry experience. They must demonstrate proficiency in statistical analysis, Gauge R&R, and optical measurement devices while having basic working knowledge of CAD/Solid Works for simple designs. Strong familiarity with GMP documentation practices and ability to write technical documents is critical.

The best fit will be local to Thousand Oaks or open to relocation, motivated to work in a hybrid on-site model, and able to show problem-solving ability and a willingness to learn.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. (See day-to-day responsibilities below).

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions. This may include, but is not limited to, the following:

• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
• Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, 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

Why is the Position Open?

Supplement additional workload on team

Top Must Have

Skills:

• Statistical analysis, and knowledge of Gage R&R (Repeatability & Reproducibility)
• Knowledge of Optical measurement devices, force testers, BLE testing
• Test method development, CAD design, Solid Works, mechanical modeling

Day to Day Responsibilities:

• Support FTE Engineers developing Methods and performing testing
• Employs basic engineering skills and practices to gather user requirements and translate them into technical documentation.
• Assist with project definition by performing engineering studies and assessment for automated test systems installations.
• Perform field evaluations of existing systems and provide engineering design recommendations.
• Create and revise documentations
• Development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.

Basic Qualifications:

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

Preferred Qualifications:

Preferred Skills

• 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 Optical measurement…