Engineer - Mechanical Design & Test Method Development (JP14414)

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/SolidWorks 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, SolidWorks, 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 devices, force testers, BLE testing Test method development, CAD design, SolidWorks, mechanical modeling Manufacturing experience, IQ, OQ, and PQ Preferred Traits: 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 Red Flags: Zero experience with combination products, but willing to consider training a junior engineer. No experience with combination products (e.g., injectors) No GMP documentation experience Candidates commuting from too far away (local to Thousand Oaks or willing to relocate) Overqualified candidates (6+ years pharmaceutical experience likely to leave quickly; PhDs too senior) Interview process: Phone screening with hiring manager, followed by final panel interview. We invite qualified candidates to send your resume to View email address on click.appcast.io. 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.