Engineer, Drug Product – Prefilled Syringes (JP13555)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
J ob Title: Engineer, Drug Product – Prefilled Syringes
(JP13555) Location: Thousand Oaks, Ca. Business Unit: PFS And Lyo
Kit Platforms Employment Type: Contract Duration: 12 months with
likely extensions or conversion to perm Rate : $36-41/hours W2 with
benefits Posting Date: 11/20/2024 Target Start Date: 01/27/2025 3
Key Consulting is hiring! We are recruiting an Engineer for a
consulting engagement with our direct client, a leading global
biotechnology company. Ideal Candidate : has hands-on experience in
engineering environments, particularly with tools like Instron
systems and optical measurement methods, as well as proficiency in
technical documentation and teamwork. They should have experience
in regulated industries, preferably biopharma, biomedical, or
medical devices, though aerospace or mechanical disciplines are
acceptable. Proficiency in Microsoft Office is required, and
CAD/SolidWorks skills are a plus. Entry-level candidates with
practical experience, such as internships, are preferred, while
overqualification (e.g., PhD or advanced degrees with extensive
experience) is less desirable. Packaging engineering knowledge is a
bonus but not mandatory. Job Description: . The Device Engineer
will participate in the design, development, and lifecycle
management 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. Essential skills and Responsibilities:
Adheres to strict documentation practices in a GMP regulated
environment Fully competent engineer in all conventional aspects of
the subject matter, functional area, and assignments, plans and
conduct work requiring judgment in the independent evaluation,
selection, and substantial adaptation and modification of standard
techniques, procedures and criteria and devises new approaches to
problems encountered. Authors and reviews technical documentation
including protocols, reports, and technical assessments Analyze and
trend generated data by applying relevant statistical techniques to
enable senior staff to make informed decisions Coordinates and
executes laboratory testing to support characterization,
verification, design transfer, and fill-finish efforts Maintains
combination product design history files for assigned products
Develops characterization test methods through fixture prototyping,
reference sample creation, and GR&R analysis 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 Individual contributor with Leadership attributes to
effectively represent device engineer within a large network/matrix
organization At a minimum familiar with the following standards and
regulations: Quality System Regulation – 21CFR820 Risk Management –
ISO 14971 EU Medical Device requirements – Council Directive
93/42/EEC Preferred Qualifications: Bachelor’s Degree or higher in
relevant engineering or scientific field (Mechanical, Biomedical,
Bioengineering) Minimum 2 year of scientific or engineering
experience in a GMP regulated environment Statistical Analysis
software (Minitab or JMP) Strong technical writing skills CAD
fixturing software (SolidWorks) Instron force tester using BlueHill
Universal Experience with design controls; including (but not
limited to) verification and design transfer Understanding of risk
assessments including hazard and probability analysis Background in
medical device development, commercialization and knowledge of
manufacturing processes (fill-finish) Ability to work independently
and dynamically across functional teams Excellent written and
verbal communication skills Ability to support complex workstreams
under demanding timelines Top Must Have Skill Sets: 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 Fully competent engineer in all conventional
aspects of the subject matter, functional area, and assignments,
plans and conduct work requiring judgment in the independent
evaluation, selection, and substantial adaptation and modification
of standard techniques, procedures and criteria and devises new
approaches to problems encountered. 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 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. 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 Red Flags: Lack of hands-on
experience in engineering or a translatable field like farming or
factory work. Poor communication or teamwork skills, especially for
candidates with no collaborative experience. Unwillingness to
relocate or commute daily to ATO for this on-site role. Weak
technical writing skills. Reliance solely on theoretical or
textbook knowledge without practical application. No experience in
relevant industries, such as medical device manufacturing,
biopharma, or packaging. PhDs or Masters candidates that have over
3 Years of experience Interview Process: Screening and then move to
1:3 team members. We invite qualified candidates to send your
resume to recruiting@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, Downey , Engineer, Drug Product – Prefilled Syringes (JP13555), Engineering , Thousand Oaks, California
