Sterilization Engineer​/Scientist Ethylene Oxide

Job Title
:
Sterilization Engineer/Scientist [Must Have Ethylene Oxide]

Location
:
Andover, MA

Duration
: 12+ Months Contract

Hours/Week
: 40.00

Shift
:
First shift, flexible with reason

Site Address
: 200 Bulfinch Dr, Andover, MA 01810

Interviews
:
Phone, video, or in person (as appropriate)

• 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.

• Lead sterilization cycle definition, development, and validation, ensuring all corresponding activities were executed and sufficiently resourced.
• Work with cross‑functional team to engage in the sterilization activities and serve as the subject‑matter expert on sterilization.
• Manage and coordinate routine sterilization including tests related to release of the lots. Tests include bioburden, product sterility test, endotoxin, EO residual testing, and BI sterility testing.
• Create and maintain standard operating procedures and work instructions 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.
• Provide cleanroom training and qualification of Embecta associates.
• Coordinate and schedule the environmental monitoring and cleaning of the Andover cleanroom.
• Investigate and resolve environmental monitoring excursions.
• Prepare environmental monitoring monthly metrics.

• BS degree in engineering, science, or technical discipline (MS preferred).
• Minimum of 3‑5 years relevant technical experience in EtO sterilization.
• Microbiology and environmental monitoring experience is a must.
• Medical device industry experience preferred.

• Excellent verbal and written communication skills.
• Extensive knowledge of ISO 10993, ISO 11135, ISO 14161, ISO 11737, ISO 14698, and ISO 14644.
• Knowledge and experience in product development with emphasis on cycle development, validation, and maintenance.
• Knowledge and experience in environmental monitoring and microbiology.