Engineer Senior, Biotechnology - (JP11209)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Senior, Biotechnology - (JP11209) Location:
Thousand Oaks, CA. Employment Type: Contract Business Unit:
Physical Testing Systems Development Duration: 15 months (with
likely extensions and/or conversion to permanent) Posting Date:
01/03/23 Notes: Only qualified candidates need apply. 100% onsite.
Monday - Friday 8am - 5pm (flex)/ 7- 4pm 3 Key Consulting is hiring
an Engineer Senior for a consulting engagement with our direct
client, a leading global biopharmaceutical 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 Skills: Test
Method development/validation experience, Equipment qualification
and implementation Experience with regulated industry, preferred
Experience with data analysis, preferred BS or Masters Degree with
a minimum of 3-4 years of 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 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 Associate'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 Red
Flags: No formal engineering training Job Jumping - multiple job
changes in a year Interview process: Phone In Person/webex 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, Ventura , Engineer Senior, Biotechnology - (JP11209), Engineering , Thousand Oaks, California
