Engineer, Life Cycle Management GMP Test Methods - Combination Products (JP13635)

Job Title: Engineer, Life Cycle Management GMP Test Methods – Combination Products (JP13635) Location: Thousand Oaks, CA. 91320 (hybrid) Business Unit: Mechanical Design Engineering Employment Type: Contract Duration: 2+ years with likely extensions and/or conversion to a permanent position. Rate: $36 - $41/hour W2 P osting Date: 1/30/2025. Notes: Only qualified candidates need apply. This is a hybrid role aligned to client's Thousand Oaks, California location, local candidates only 3 Key Consulting is hiring! We are recruiting an Engineer Life Cycle GMP Test Methods – Combination Products for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: 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. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate 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. 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 Factory Acceptance Testing (FAT) / Site Acceptance Testing (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

Top Must Have Skill Sets:

• 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

Day to Day Responsibilities:

• Support FTE Engineers developing Methods and performing testing
• Create and revise documentations

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:

• 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
• 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 we are willing to consider training a junior engineer. 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.