Engineer Principal, Biotechnology – (JP11093)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Principal, Biotechnology – (JP11093)
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: 11/22/22 Notes: Only qualified candidates need apply.
100% onsite. Monday - Friday 8am - 5pm (flex)/ 7 am - 4pm 3 Key
Consulting is hiring an Engineer Principal 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
client supply chain, Quality, or manufacturing labs at all client
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 client
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 client 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 Top Must Have Skills: Technical writing
experience - minimum 2 years Experience with regulated industry
Pharma, Biotech, preferred Experience with managing projects and
teams Masters, PhD degree, Bachelors with minimum 8 years Day to
Day Responsibilities: 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 client supply chain, Quality, or
manufacturing labs at all client sites. The principal engineer must
ensure documentation can withstand an audit and pass agency
scrutiny. Basic Qualifications: 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, OR Associate’s degree and 10 years of
engineering experience, OR High school diploma / GED and 12 years
of engineering experience AND 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 Red Flags: No
formal engineering training No BS degree Job jumping - mulitple job
changes within the year 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, Diamond Bar , Engineer Principal, Biotechnology – (JP11093), Engineering , Thousand Oaks, California
