3 Key Consulting, Inc.

Sterilization Senior Engineer, Biotech Manufacturing (JP14138)

3 Key Consulting, Inc.  •  $44 - $50/hr  •  Cambridge, MA (Onsite)  •  10 days ago
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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. 

 

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.


3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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