Engineer - (JP10047)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer - (JP10047) Location: Thousand Oaks, CA.
91320 Employment Type: Contract Business Unit: Physical Testing
Development Duration: 18 months (with likely extensions) Notes:
Remote Posting Date: 04/07/2022 3 Key Consulting is hiring an
Engineer for a consulting engagement with our direct client, a
leading global biopharmaceutical company. Job Description: The
Engineer, in Final Product Technologies- Mechanical Engineering
Methods, is 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. The Engineer shall
have the ability to work on multiple projects at one time that may
involve changes or new product, processes, tooling or equipment
introduction to improve quality and reliability and reduce cost.
Phases of projects include: developing combination product test
methods, providing key expert support for qualification,
validation, transfer, and life cycle support of methods for
manufacturing, new product introduction, training, and production
support. Why is the Position Open? Supplement additional workload
on team. Top Must-Have Skill Sets: 3D Design, CAD, Solid Works
experience (at least 2 years of experience) Technical Writing
Manufacturing, validation, qualification processes Day to Day
Responsibilities: Develop, qualify, and validate GMP physical test
methods for vials, prefilled syringes, and injection devices. Work
in teams to transfer new combination product test method and
assembly requirements to manufacturing, by developing six sigma
processes and compiling documentation for manufacturing assembly
requirements. Develop, qualify, validate, and transfer new
equipment, software, systems, and methods. Implement projects per
Final Product Technologies and company procedures to ensure
projects are completed on schedule and within established budget.
Provide expert support for investigations as well as new process
development required to improve manufacturing operations.
Coordinate test method development and delivery with selected
contractors. Ensure that qualification parameters are met for
product assembly requirements. Support development of cost
estimates for new processes, gauges and equipment development used
in generation of capital request documentation. Generate procedures
necessary to support department and new process equipment. Provide
expert training to individuals in the operation and maintenance of
processes, test methods and equipment introduced to Quality Control
and/or the manufacturing department (i.e. production operator,
mechanics, process engineers). Participate in and assume
responsibilities of team functions as assigned (i.e. Product
Improvement Teams). Generate/author and own the Test Method
documents. 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
Maintains integrated timelines capturing appropriate cross
functional details and deliverables which are aligned with the
functional and project goals Networks internally to ensure
alignment, commitment to project objectives and timelines as well
as to ensure effective execution of projects Networks with
manufacturing, quality and regulatory organizations both internal
and external to client Drives the cross-functional communication
and integration of information to optimize decision making, issue
resolution and change management throughout project lifecycle
Excellent verbal and written communication skills are utilized to
communicate project status and risks associated with integrated
timelines to leadership Collaborates with other functional leaders
to ensure project success, momentum and commitment Proactively
identifies issues and/or risks and develops mitigation options to
resolve or escalate efficiently Integrates partner/vendor timelines
with client timelines as appropriate Red Flags: No B.S. degree in
engineering or technical field No 3D design or CAD experience No
technical writing Interview process: Phone screening followed by
in-person 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, Newport Beach , Engineer - (JP10047), Engineering , Thousand Oaks, California
