Engineer, Prefilled Syringe Design and Test (JP13742)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer, Prefilled Syringe Design and Test (JP13742)
Location: Thousand Oaks, CA. 91320 Business Unit: Prefilled
Syringes & Lyo Kit Platforms Employment Type: Contract Duration: 1
year with likely extensions and/or conversion to a permanent
position. Rate: $36 - $41/hour W2 Posting Date: 02/26/2025. Notes:
Only qualified candidates need apply. 3 Key Consulting is hiring!
We are recruiting an Engineer, Prefilled Syringe Design and Test
for a consulting engagement with our direct client, a leading
global biotechnology company. Job Description: The Device Engineer
will participate in the design, development, and lifecycle
management of design control activities for commercialized drug
delivery devices. This role includes technical operations support
for combination product development to global launch, clinical and
commercial manufacturing, failure investigation, design change
evaluation, development and execution of test procedures, and
continuous improvement initiatives. Scope includes mechanical
delivery devices, such as Prefilled syringes. The qualified
candidate will be part of a sustaining device engineering team that
ensures design history files of these mechanical delivery devices
are maintained. The engineer will participate in cross functional
teams, leading device design activities such as the development of
product enhancements, analytical failure analysis and
implementation of design solutions, assessment of proposed changes,
support product launches, defend inspection and ensure the follow
through of commitments. Top Must Have Skill Sets: • Hands on
Laboratory Experience in a GLP Setting (Science or Engineering Lab)
• GMP and GDP Technical Writing Skills • CAD experience or
knowledge (such as Solidworks) Day to Day Responsibilities: The
device engineer will support a senior engineer on a variety of
projects related to laboratory testing, life cycle management, and
product-based initiatives regarding prefilled syringes in both the
commercial and developmental space. The engineer will be expected
to author protocols, reports, and further technical documentation
while adhering to GMP and GDP standards. Laboratory testing will
primarily include the use of an Instron force tester and vision
systems. The identified candidate must be able to lift up to 50 lbs
for receipt and transferring of material. Fill-Finish experience is
a bonus but not mandatory. Engineer will be evaluated on ability to
complete a wide variety of supporting tasks for projects in a
timely manner while maintaining a high standard of quality. •
Adheres to strict documentation practices in a GMP regulated
environment • Engineering competency in all conventional aspects of
the subject matter, functional area, and assignments • Plans and
performs work, independently evaluating, selecting, and adapting
standard methods, and creating new solutions to engineering
problems. • Authors and reviews technical documentation including
protocols, reports, and technical assessments • Coordinates and
executes laboratory testing to support characterization,
verification, design transfer, and fill-finish efforts • Analyze
and trend generated data by applying relevant statistical
techniques to enable senior staff to make informed decisions •
Maintains device and combination product design history files for
assigned products • Ensure test methods and test protocols are
developed in a sound and robust framework with high focus on
eliminating test errors • Provides functional subject matter
expertise to actively participate in cross-functional activities
including system level root cause analysis, design changes, and
change control assessments • Provide general laboratory support
including inventory management, sample shipments, and cleanup. •
Works with Scientists and Engineers, to assess and develop
appropriate design and manufacturing specifications Basic
Qualifications: Master degree OR Bachelor degree and 2 years of
experience OR Associate degree and 6 years of experience OR High
school diploma / GED and 8 years of experience Preferred
Qualifications: • Bachelor’s Degree or higher in relevant
engineering or scientific field (Mechanical, Biomedical,
Bioengineering) • Understanding of Mechanical Design Engineering
Concepts • Experience with Final Drug Product and/or Drug Product,
medical device development, commercialization and knowledge of
manufacturing processes (fill-finish) • Experience with design
controls; including (but not limited to) design verification and
transfer • Understanding of risk assessments including hazard and
probability analysis • Experience with investigations and quality
records • Laboratory and electronic lab notebook experience •
Statistical Analysis software (Minitab or JMP) • Experience with
Instron force testers using BlueHill Universal • Test method
development, GR&R, and text fixture design • Ability to work
independently and dynamically across functional teams • Strong
technical writing and verbal communication skills including
technical presentations (i.e., PowerPoint) • Ability to support
complex workstreams under demanding timeline • Understanding of the
following standards and regulations: Quality System Regulation –
21CFR820; Quality Management System for medical device/component
manufacturers - ISO 13485 Risk Management for Medical Devices – ISO
14971; EU Medical Device Regulation – 2017/745 Red Flags: • No GxP
laboratory experience • 2. No GDP experience • 3. Only academic
technical writing experience (non-industry setting) Why is the
Position Open? Backfill Interview Process: • Virtual 1 on 1
interview with hiring manager • Virtual 1 on 1 interview with
organization department manager • Panel interview (2-3 colleagues)
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, Bellflower , Engineer, Prefilled Syringe Design and Test (JP13742), Engineering , Thousand Oaks, California
