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Job Title Sterilization Engineer/Scientist [Must Have Ethylene Oxide]
Location Andover, MA
Duration 12+ Months Contract
Total Hours/week - 40.00
Shift hours: First shift, flexible with reason
Site Location Address: 200 Bulfinch Dr, Andover, MA 01810
Interviews phone, video or in person: Can be video or in person as appropriate
3 Must Haves On The Resume
Ethylene Oxide sterilization and validation experience
Microbiology experience
Environmental monitoring experience
Lead efforts to develop sterilization cycle and methodologies for new product development. This position will also be accountable in managing Andover cleanroom/s.
Responsibilities
Lead sterilization cycle definition, development, and validation, ensure that all corresponding activities were executed and sufficiently resourced.
Work with cross functional team engage in the sterilization activities and be the subject matter expert pertaining to sterilization.
Manage and coordinate routine sterilization including test related to release of the lots. Tests include Bioburden, Product sterility test, Endotoxin, EO Residual testing and BI sterility testing.
Creation and maintenance of standard operating procedure and work instruction related to sterilization, Environmental monitoring, and Microbiology.
Manage and maintain the Andover Environmental Monitoring program including coordinating maintenance activities related to cleanroom and critical utilities.
Cleanroom training and qualification of embecta associates.
Coordinate and schedule the environmental monitoring and cleaning of the Andover cleanroom.
Responsible for the investigation and resolution of EM excursions.