Engineer, GMP Drug Delivery Medical Device (JP13653T)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, GMP Drug Delivery Medical Device (JP13653C)
Location: Cambridge, MA 02138 OR Thousand Oaks, Ca. Business Unit:
Physical Methods Development, Modelling and Emerging Method
Employment Type: Contract Duration: 12 months with likely
extensions or conversion to perm Rate : 38-42$/hours W2 with
benefits Posting Date: 1/27/2025 Target Start Date: 2/24/2025 3 Key
Consulting is hiring! We are recruiting an Engineer for a
consulting engagement with our direct client, a leading global
biotechnology company. Ideal Candidate : Ideal candidate: 3 YOE in
field desired with bachelors. 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. 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 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 company
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, experience with MS Project Top Must Have Skill
Sets: Excellent verbal and written communication skills to
communicate project status and risks associated with integrated
timelines to leadership Mathematical background fundamentals of
statistics Ability to manage multiple, competing priorities
simultaneously, Day to Day Responsibilities: Collaborate with
Engineers using the system to edit, develop, and run automated,
experimental protocols. Run Gauge Repeatability and Reproducibility
studies Assisting Engineers to successfully develop, transfer and
execute processes on the integrated platforms and equipment. 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 Employee Value
Proposition: Possibility of extension or conversion if FTE position
comes available. Interview Process: Phone Screening Panel Interview
We invite qualified candidates to send your resume to
recruiting@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, Arcadia , Engineer, GMP Drug Delivery Medical Device (JP13653T), Engineering , Thousand Oaks, California
