Engineer - (JP9594)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer - (JP9594) Location: Thousand Oaks, CA.
Employment Type: Contract Business Unit: Modeling and Emerging
Technologys Duration: 1 years (with likely extensions and/or
conversion to permanent) Posting Date: 12/28/2021 Notes: 3 Key
Consulting is hiring an Risk Management Senior Associate for a
consulting engagement with our direct client, a leading global
biopharmaceutical company. Job Description: Position requires B.S.
in Mechanical Engineering, Chemical or Biomedical Engineering, or
Materials Science. 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 Skills:
3D Design in CAD, SolidWorks. Technical Writing Skills.
Qualification or Validation Experience with equipment, systems,
software. 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 Employee Value Proposition:
The person in this position will work to build test methods to
determine if products are ready to go out to market. This team
focuses mostly on device design, failure analysis. Red Flags: No
B.S. in Mechanical Engineering, Chemical or Biomedical Engineering,
or Materials Science. No 3D Design Software, CAD, SolidWorks. No
technical writing skills. No communication skills. Interview
process: Video Skype 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, Gardena , Engineer - (JP9594), Engineering , Thousand Oaks, California
