Senior Engineer – Sterilization and Process Development
Location : Cambridge, MA
Contract Duration : 1 Year (with potential for extension)
Target Pay Rate : $45 per hour
Basic Qualifications
- Doctorate degree , or
- Master’s degree 3 years of relevant experience, or
- Bachelor’s degree 5 years of relevant experience, or
- Associate degree 10 years of relevant experience, or
- High school diploma / GED 12 years of relevant experience
Position Overview
This position is open due to increased workload, and we are looking for an individual to contribute to a multi-disciplinary team that supports the sterilization process development for combination products. We are ideally seeking someone local to the Cambridge, MA area but are open to relocation candidates with the right skillset, particularly in sterilization.
Top 3 Must-Have Skills
Sterilization experienceQualification / Quality experienceCommercial process lifecycle managementResponsibilities
The Senior Engineer will support, lead, and manage various processes related to gas sterilization of combination products. Day-to-day responsibilities include :
Support and lead process development and commercialization of gas sterilization processes for combination products.Coordinate and lead manufacturing site requirements for sterilization processes.Support the design control process and qualification of primary components.Lead and support technical transfer projects for combination products.Develop and implement operational improvements with key primary component suppliers.Contribute to the development of characterization methods for mechanical and physical properties of primary components.Support ongoing deviation, CAPA (Corrective and Preventive Action), and change control efforts.Lead sterility assurance assessments for suppliers / raw materials.Collaborate with internal and external stakeholders, including manufacturing, suppliers, quality, regulatory, and senior management.Drive technical discussions and influence key opinion leaders through technical papers, presentations, and participation in key conferences.Employee Value Proposition
Career growth opportunitiesGain diverse experience in a fast-paced environmentPossible Extension
Yes, potential for contract extension based on performance and workload.
Interview Process
Phone interview followed by an in-person interview.Interviews can begin as early as next week.Preferred Qualifications
3 years of experience in ethylene oxide or other gas sterilization processes.3 years of experience in sterility assurance for combination products.3 years of experience in ethylene oxide, moist heat, and / or vaporized hydrogen peroxide sterilization.Ability to read and interpret business periodicals, professional journals, technical procedures, or governmental regulations.Strong problem-solving skills and the ability to manage multiple projects in a fast-paced environment.Excellent communication, presentation, and organizational skills.
Salary : $45
