Engineer Senior Biotech Sterilization JP13707
Engineer Senior Biotech Sterilization JP13707
Posted on :
11-04-2025
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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 multidisciplinary program team to build drug delivery solutions which meet user requirements for clients 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 wellsupported 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 ongoing deviation/ CAPA and change control
support/ lead clients 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 problemsolving 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 If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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 multidisciplinary program team to build drug delivery solutions which meet user requirements for clients 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 wellsupported 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 ongoing deviation/ CAPA and change control
support/ lead clients 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 problemsolving 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 If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/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
Employment Type
Hourly
Key Skills
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