Engineer, GMP Test Methods Medical Device – (JP10960)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer, GMP Test Methods Medical Device – (JP10960)
Location: Thousand Oaks, CA. 91320 Employment Type: Contract
Business Unit: Physical Testing Systems Development Duration: 18
months (with likely extensions and/or conversion to permanent)
Posting Date: 10/25/22 Notes: Only qualified candidates need apply.
3 Key Consulting is hiring an Engineer for a consulting engagement
with our direct client, a leading global biopharmaceutical company.
Job Description: The Engineer will work under the team: Physical
Science and Engineering CCI ( Container Closure Integrity), testing
of syringes in the Device and Packaging Engineering lab. Research &
Development. Lab Experiment . They will be responsible for
engineering activities required for the development, qualification,
validation, and transfer of Physical GMP Test Methods for
combination products, devices, primary containers, and secondary
packaging components. Position involves support of senior staff in
the initiation, design, and delivery of projects, particularly for
Container Closure Integrity (CCI). Employ basic engineering skills
and practices to gather user requirements and translate them into
technical documentation for execution. Assist with project
definition by performing engineering studies and assessment for CCI
systems. Perform field evaluations of existing systems and provide
engineering design recommendations. Top Must Have Skills:
Bachelors, must have (Engineering or Biomedical,STEM) Must have
experience in work or laboratory settings (will consider new grads)
Experience with Statistical Software, perferred SolidWorks - or
Computer Aided Design (cad) experience, perferred MSA experience
(Measurement System Analysis) training is a plus - Our team uses
this for measuring the abilities of the processes we design. Day to
Day Responsibilities: Develop, qualify, and validate GMP physical
test methods for vials, prefilled syringes, and injection devices.
Provide support of senior staff for delivery of Projects.
Coordinate test method development and delivery with selected
contractors and vendors. Ensure that qualification parameters are
met for product requirements. Generate procedures necessary to
support department and new process equipment. Maintains integrated
timelines capturing appropriate cross functional details and
deliverables which are aligned with the functional and project
goals. Participate in and assume responsibilities of team functions
as assigned – i.e. subject matter experts for test equipment
Generate/author and own the Test Method documents: Procedures,
engineering drawings, specifications, protocols, reports, etc.
Gather test method requirements that result in equipment that
operates safely and considers ergonomic factors in the design.
Perform other duties as required by the Group Manager. Comply with
the requirements, responsibilities, and authority as required.
Communicate and collaborate internally to ensure alignment,
commitment to project objectives and timelines as well as to ensure
effective execution of projects. Network with manufacturing,
quality and regulatory organizations both internal and external to
client. Excellent verbal and written communication skills are
utilized to communicate project status and risks associated with
integrated timelines to leadership. Basic Qualifications: Previous
work experience is a plus. SolidWorks 3D CAD FEA. Minitab. JMP.
Experience working in team. Red Flags: No Bachelors Degree Degree
not related to STEM or Biomedical No mechanical aptitude - no
experience using tools, building or designing and assembly or
disassembly of equipment/components. No CAD use. Interview process:
Phone screening Webex 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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Los Angeles , Engineer, GMP Test Methods Medical Device – (JP10960), Engineering , Thousand Oaks, California
