Sterilization Senior Engineer, Biotech Manufacturing

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 . 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 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