Principal Engineer, Biotech Medical Device (JP10973)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Principal Engineer, Biotech Medical Device (JP10973)
Location: Thousand Oaks, CA. 91320 Employment Type: Contract
Business Unit: Physical Testing Systems Development Duration: 18
months with likely extensions and/or conversion to permanent
Posting Date: 10/28/22 3 Key Consulting is hiring Principal
Engineer for a consulting engagement with our direct client, a
leading global biopharmaceutical company. Job Description:
Reporting to the Director Physical Sciences and Engineering,
Manufacturing Sciences and Technology (MSAT), the successful
candidate for this position will manage (projects, personnel, and
laboratory) an engineering group responsible for development of
innovative solutions to complex biotechnology device and packaging
problems based on insightful interpretation and analysis of the
problem statement or investigation. These key activities serve MSAT
in the development of physical methods, characterization studies,
and design verification deliverables for CPO. The principal
engineer will operate in a highly matrixed environment to
collaborate effectively with cross functional teams. The principal
engineer is responsible to critically analyze department
requirements, ensure documentation and laboratories maintain proper
state of qualification, calibration and preparedness for
inspections related to safety, compliance and procedures. The
principal engineer must also clearly communicate and elevate
technical or strategic issues to team members and management as
needed and make robust recommendations and/or decisions to guide
successful execution of mechanical testing for primary containers,
device and packaging test methods. Group members within the
functional area look up to this position as a scientific/technical
expert who can provide guidance on associated issues as needed.
Demonstrated supervisory skills are required. Responsibilities
include managing a team to: Own and maintain business processes for
development, qualification, validation and transfer of physical
test methods for product verification of new products, and transfer
of validated methods to enterprise supply chain, Quality, or
manufacturing labs at all company sites. The principal engineer
must ensure documentation can withstand an audit and pass agency
scrutiny. Develop and own Standard Operating Procedures for data
creation, storage, retention, and audit in accordance with Title 21
CFR Part 11 Compliance for all lab testing and associated 21CFR 820
requirements for device development. Rapidly design, develop,
qualify, and innovate automated inspection equipment for company’s
primary containers and devices to meet new and unique product
requirements. Work with Device Technologies to advance state of the
art physical methods and other emerging technologies to
characterize, evaluate, and release combination products, primary
containers, and secondary packaging. The candidate is expected to
support input data solutions going into Device Master Records and
associated work product with clinical and commercial manufacturing
for combination products, primary containers, and secondary
packaging. Design, develop and execute mechanical testing using
phase appropriate controls for the development and qualification of
primary container platforms and medical devices to develop
specifications. Facilitate communication with company sites and
vendors to establish user requirements for the characterization of
primary packaging components used in the commercialization of drug
products and devices Work closely with facilities, maintenance,
instrumentation, and electrical systems to ensure laboratory
equipment is maintained in compliance with all industry,
regulatory, corporate, and regulatory standards. Ensure laboratory
compliance for quality audits utilizing internal and external
calibration laboratories, vendors and suppliers. Advise others on
methods of resolving measurement problems. Keep current with
information from other industry experts through participation in
government and industrial standardization committees and
professional societies Basic Qualification Doctorate degree and 2
years of engineering experience OR Master’s degree and 6 years of
engineering experience OR Bachelor’s degree and 8 years of
engineering experience 2 years of managerial experience directly
managing people and/or leadership experience leading teams,
projects, programs or directing the allocation of resources
Preferred Qualifications: Degree in Engineering, MBA or related
field 8 years of experience with 3 years’ experience in leading a
highly matrixed physical characterization metrology laboratory in a
highly regulated environment Experience including managing a lean,
high performing technical staff for 3 years, direct experience in
optimization of equipment designs, physical methods, statistical
design (Six sigma is highly desired), geometric dimensions and
tolerances, kinetic modeling, Solid Works engineering drawing, DOE,
and DFM tool sets Formal education in project management Excellent
problem solving, trouble shooting, and communication skills.
Ability to participate in global cross-functional teams and work
effectively in a highly matrixed team environment with rapidly
evolving challenges Demonstrated competencies skills and proven
track record of leading cross-functional projects, ability to coach
junior engineers, strong team work, excellent interpersonal and
communication skills Experience with MS Office Suite, MS
SharePoint, MS Project, Minitab/JMP, SolidWorks Top Must Have
Skills: Technical writing experience - minimun 2 years Experience
with regulated industry , Pharma, Biotech, preferred Experience
with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP,
SolidWorks Experience with managing projects and teams Masters, PhD
degree, Bachelors with minimun 8 years Red Flags: No formal
engineering training No BS degree Job jumping - multiple job
changes within the year Interview process: Phone Panel interview
via WebEx We invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to take a
look at the other positions on our website
www.3keyconsulting.com/careers. You are welcome to also share this
opportunity with anyone you think might be interested in applying
for this role Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Hacienda Heights , Principal Engineer, Biotech Medical Device (JP10973), Engineering , Thousand Oaks, California
