Engineer Senior, Biotech Sterilization (JP13707)
Company: 3 Key Consulting
Location: Cambridge
Posted on: April 2, 2026
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Job Description:
Job Title : Engineer Senior, Biotech Sterilization (JP13707)
Location : Cambridge, MA. 02138 Business Unit: Manufacturing
Science and Technology Employment Type: Contract Duration: 1 year
with likely extensions and/or conversion to a permanent position.
Rate: $44 - $50/hour W2 Posting Date : 02/17/2025. Notes: Only
qualified candidates need apply. 3 Key Consulting is hiring! We are
recruiting an Engineer Senior, Biotech Gas Sterilization for a
consulting engagement with our direct client, a leading global
biotechnology company. Job Description: The Senior Engineer works
as part of a multi-disciplinary program team to build drug delivery
solutions which meet user requirements for client’s portfolio of
therapeutic products from concept through commercial entry. The
individual advances technical programs, contributing to definition
of design requirements, identification and realization of technical
solutions, authoring of test methods and reports, and authoring of
technical analyses to advance programs. The successful candidate
establishes well-supported insights for development, clinical and
commercial stage solutions to serve user needs and the needs of the
pipeline portfolio, using a range of program tools, design
characterization and verification methods, and design reviews. S/he
ensures that the required performance and quality targets are
satisfied and helps identify and reduce technical risks on the
program. Top Must Have Skill Sets: • Sterilization experience •
Qualification/ quality experience • Commercial process lifecycle
management Ideally looking for someone locally but open to someone
who will relocate with the proper and strong sterilization
experience Day to Day Responsibilities: • support/ lead process
development and commercialization of gas sterilization processes of
combination products • coordinate/ lead manufacturing site
requirements to support sterilization requirements • support the
design control process and qualification of primary components •
support/ lead tech transfer projects for combination products •
support/ lead the development and operational improvements with key
primary component suppliers • support development of
characterization methods for mechanical and physical properties of
primary components • support on-going deviation/ CAPA and change
control • support/ lead client’s supplier/ raw materials sterility
assurance assessments • collaborate extensively with internal and
external stakeholders i.e. manufacturing, suppliers, quality,
regulatory, senior management, etc. • drive and influence key
opinion leaders by providing technical papers, presentations and
attending key conferences Basic Qualifications: • Doctorate degree
OR Master degree and 3 years of experience OR Bachelor degree and 5
years of experience OR Associate degree and 10 years of experience
OR High school diploma / GED and 12 years of experience • 3 years
in ethylene oxide or other gas sterilization processes • 3 years
industry experience in sterility assurance of combination products
• 3 years in ethylene oxide, moist heat, and/ or vaporized hydrogen
peroxide sterilization • Ability to read, analyze and interpret
general business periodicals, professional journals, technical
procedures, or governmental regulations • Strong problem-solving
skills • Capability to advance multiple projects in a fast paced
environment • Strong oral and written communication skills,
decision making, presentation, and organization skills • Basic
Qualifications Interview Process: Phone and In Person Why is the
Position Open? Supplement additional workload on team 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, Brookline , Engineer Senior, Biotech Sterilization (JP13707), Engineering , Cambridge, Massachusetts
