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
Posting Date: 1/30/2025.
Notes: Only qualified candidates need apply. This is a hybrid role aligned to clients 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 wellconstructed 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 industryleading 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 If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.