Sterilization Senior Engineer, Biotech Manufacturing (JP14138)
Company: 3 Key Consulting
Location: Cambridge
Posted on: April 2, 2026
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Job Description:
Job Title : Sterilization Senior Engineer, Biotech Manufacturing
(JP14138) 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 with benefits Posting
Date : 05/23/2025. 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 Preferred Qualifications: 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 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 Employee Value Proposition: Career
growth Opportunity Experience 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, Worcester , Sterilization Senior Engineer, Biotech Manufacturing (JP14138), Engineering , Cambridge, Massachusetts
