Job Title: Engineer – Mechanical Design & Test Method Development (JP14414)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: Mechanical Design EngineeringDuration: 18+ months (with likely extensions and/or conversion to permanent)Posting Date: 09/04/25Pay Rate: $36 - $41/hour W2Notes: Only qualified candidates need apply. Thousand Oaks Local Candidates Only. Potential for Hybrid. 18 months with possible 18-month extension based on performanceOverview3 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 studiesAssisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.Developing, enhancing, automating, and managing test dataNetwork with manufacturing and quality organizations internal to clientEnsuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPsMonitoring technological developments in the field & evaluation of new technologiesWhy is the Position Open?Supplement additional workload on teamTop Must Have Skills:Statistical analysis, and knowledge of Gage R&R (Repeatability & Reproducibility)Knowledge of Optical measurement devices, force testers, BLE testingTest method development, CAD design, SolidWorks, mechanical modelingDay to Day Responsibilities:Support FTE Engineers developing Methods and performing testingEmploys 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 documentationsDevelopment 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 experiencePreferred Qualifications:Preferred SkillsExperience working in a regulated industry, exposure to GMPsExcellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadershipStatistical analysis, and knowledge of Gage R&RKnowledge of Optical measurement devices, force testers, BLE testingTest method development, CAD design, SolidWorks, mechanical modelingManufacturing experience, IQ, OQ, and PQPreferred Traits:Passion for proactively identifying opportunities through creative data analysis and modelingIntellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs ariseAbility to manage multiple, competing priorities simultaneously, experience with MS Project, SmartsheetRed 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 experienceCandidates 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 resumes@3keyconsulting.com. 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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.#J-18808-Ljbffr