Engineer, Test Methods and Execution (JP12978)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 5, 2026
|
|
|
Job Description:
Job Title: Engineer, Test Methods and Execution (JP12978)
Location: Thousand Oaks, CA. 91320 (hybrid, 2-3 days onsite)
Business Unit: Physical Methods Development, Modelling and Emerging
Methods Employment Type: Contract Duration: 1 years (with possible
extensions) Rate : $38 - $42 Posting Date: 8/11/2024. Notes: Only
qualified candidates need apply. Hybrid, 2-3 days onsite in
Thousand Oaks, CA. 3 Key Consulting is hiring! We are recruiting an
Engineer for a consulting engagement with our direct client, a
leading global biotechnology company. Job Description: Our ideal
candidate will have: 3 YOE in field desired with bachelor’s degree.
Experience working in a regulated industry, exposure to GMPs,
Medical Device experience is highly desired. Mathematical
background fundamentals of statistics. Useful to have exposure to
test method development, CAD design, SolidWorks, mechanical
modeling. Nice to have programming R and Python experience. Hands
on technical experience useful, comfortable working within a lab.
Position involves support of senior staff in the initiation,
design, and delivery of projects, particularly for automation
related projects in the Process Development Organization, within
the Combination Product Operations. The candidate will be a part of
the Commercial Platform Methods and Automation team where the
responsibilities include 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 FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge
Repeatability and Reproducibility studies. Troubleshooting of
various lab instruments and automation systems, which will require
learning the specific software controlling the instruments and
integrated systems from vendor manuals, and site documents.
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. 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. Top Must Have Skill Sets: 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 Day to Day
Responsibilities: Develop testing protocols. Execute tests in the
lab. Write reports and technical assessments. Communicate project
status, maintain project plans. 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: Nice to have programming R
and Python experience. Hands on technical experience useful,
comfortable working within a lab. Why is the Position Open? Planned
Project. Interview Process: 2 Teams meetings 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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Laguna Niguel , Engineer, Test Methods and Execution (JP12978), Engineering , Thousand Oaks, California