Engineer, Medical Device - GMP Test Methods (JP11103)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer, Medical Device - GMP Test Methods (JP11103)
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: 12/29/2022 Notes : Onsite - Shift/Schedule: Monday -
Friday, 8am - 5pm, 9 am - 6:00 pm (flexible) 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. 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. 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
various systems. Perform field evaluations of existing systems and
provide engineering design recommendations. Skills : previous work
experience is a plus. SolidWorks 3D CAD FEA. Minitab. JMP.
Experience working in team. 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 Top Must Have Skills: Technical writing
experience - 1-3 years of experience Engineering - 1-3 experience
New grads considered - BS at minimum (engineering, mechanical,
biomed) Excellent verbal/written communication skills. Solids
works, CAD, required . PLUS - Qualification and validation, and/or
statistical experience 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 Red Flags: Large periods of unemployment No degree in
engineering or science Does not work well in teams. No experience
with Solidworks and CAD Interview process: Phone screen - 30 min
Video Call with Hiring manager and panel of engineers from same
group. We invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to take a
look at the other positions on our website
www.3keyconsulting.com/careers. You are welcome to also share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Fountain Valley , Engineer, Medical Device - GMP Test Methods (JP11103), Engineering , Thousand Oaks, California
