Sterility Assurance Engineer II

Job Description Summary

Performs complex technical work pertaining to sterilization and microbiology such as validations and product adoptions under broad supervision and guidelines.

ESSENTIAL FUNCTIONS PERFORMED

• Writes sterilization validation protocols and final reports.

• Coordinates and executes sterilization validations, including annual requalification’s and dose audits as necessary.

• Monitors the environmental monitoring program for the cleanrooms.

• Performs and documents product adoptions into existing EO sterilization cycles using the appropriate standards.

• Communicates and interfaces with contract sterilizers and laboratories.

• Works independently on standard projects while assistance is furnished on unusual problems.

• Receives guidance on specific assignment objectives, complex features, and possible solutions.

• May supervise the work of technicians in the team.

• Completes investigation and disposition of complex NC’s as applicable.

• Manages compliance to Sterility Assurance and Environmental metrics including NC timeliness.

• Works on special projects, writes ECN's, and leads continuous improvement activity.

• Oversees Environmental Monitoring programs for cleanrooms.

• Supports both internal and external audits.

• Performs other duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- up to 50 lbs. – local practice may apply.

• Writing

• Sitting

• Standing

• Bending

• Vision

• Color perception

• Depth perception

• Reading

• Field of vision/peripheral