Engineer Senior, Validation Physical Test Methods Combination Devices - Hybrid (JP12037)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Senior, Validation Physical Test Methods
Combination Devices - Hybrid (JP12037) Location: Thousand Oaks, CA.
91320 Business Unit: Physical Testing Systems Development
Employment Type: Contract Duration: 6 monthss (with possible
extensions) Rate : $46 - $51/hour W2 Posting Date: 12/18/2023
Notes: Only qualified candidates need apply. Hybrid – Must be local
to Thousand Oaks, CA. as follows: Monday, Wednesday, Friday
(Remote) Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm 3
Key Consulting is recruiting an Engineer Senior, Validation
Physical Test Methods Combination Devices for a consulting
engagement with our direct client, a leading global biotechnology
company. Job Description: The Senior Engineer is responsible for
engineering activities required for development / qualification /
validation and transfer of GMP physical test methods for
combination products, devices, primary container, and secondary
packaging components, as required. This individual shall have the
ability to work on multiple projects at one time that may involve
either new or changed product, process, tooling or equipment
introduction to improve product quality and reliability. Top Must
Have Skill Sets: Experience performing data analysis using
statistical software, (JMP, Minitab) Experience modeling test
fixtures, reference samples on solidworks or any other CAD software
Root cause analysis, CAPA deviation Equipment method and test
validation experience Technical writing experience Day to Day
Responsibilities: Assure transfer of new combination product test
methods to QC or manufacturing, by developing six sigma processes
and compiling all required documentation. Implement projects per
Combination Product Operations (CPO) and company procedures to
ensure projects are completed on schedule and within established
budget. Apply core engineering principles to develop physical test
methods for medical device and combination product systems. Perform
data analysis to support method development, qualification,
validation, and transfer Provide expert support in the design or
redesign of tools and/or equipment required for manufacturing
processes. Provide expert support for investigations as well as new
processes development required to improve manufacturing operations.
Improvements may be required for a variety of reasons (i.e.
quality, reliability, new product introduction, cost saving).
Coordinate gauge and equipment development and delivery with
selected contractors. Ensure that qualification parameters are met
for product assembly and performance 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 product equipment. Provide expert training to individuals
in the operation and maintenance of processes, gauges and equipment
introduced to 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). Supervise work of support staff during
development and manufacture of system. Excellent communication
(written and verbal) and organizational skills Develops and
maintains integrated timelines capturing appropriate cross
functional details and deliverables which are aligned with the
functional and project deliverables Networks with manufacturing,
quality and regulatory organizations both internal and external to
client Facilitates robust horizontal communication to ensure all
functions are aware of changes in deliverables and impacts to risk.
Proactively identifies issues and/or risks and develops mitigation
options to resolve or escalate efficiently Integrates
partner/vendor timelines with client timelines as appropriate Basic
Qualifications: Doctorate Degree OR Master's Degree and 3 years of
Engineering experience OR Bachelor's Degree and 5 years of
Engineering experience OR OAssociate's degree and 10 years of
Engineering experience OR High school diploma/GED and 12 years of
Engineering experience. Preferred Qualifications: M.S. or Ph. D. in
Mechanical, Aerospace, Mechatronics, Chemical or Biomedical
engineering Excellent written and verbal communication skills
together with demonstrated ability to work in a highly matrixed
team environment Experience with managing technical teams,
including setting priorities and leveling resources Technical
writing experience Spanish language skills preferred Experienced
with SolidWorks (or other 3D-CAD software) Familiar with equipment
and software IOQ Experience with process characterization,
scale-up, technology transfer experience, pFMEAs and dFMEAs
Experience with change controls, deviations, CAPA Experience with
combination products and device regulatory requirements
Understanding of the six sigma process, utilizing Minitab (or other
statistical software packages) to solve statistical problems Work
history with cGMPs, regulatory filings and compliance issues for
sterile injectable products manufactured by aseptic processing
Experience with machine controls (PLC, HMI) and vision systems Why
is the Position Open? Supplement additional workload on team Red
Flags: No engineering background. No CAD background. No
troubleshooting and root cause investigation experience. No data
analysis experience. No technical writing experience Lack of
experience working in technical team / team work Interview Process:
1st initial phone screen 2nd interview in person panel 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, Aliso Viejo , Engineer Senior, Validation Physical Test Methods Combination Devices - Hybrid (JP12037), Engineering , Thousand Oaks, California
