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
SUMMARY OF MINIMUM QUALIFICATIONS
- Education equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry
- 3-5 years of experience in sterilization
- Advanced English level
- Ability to apply analytical skills and scientific technical principles in problem solving and development.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- Stro
📌 Sterility Assurance Engineer II (Tijuana)
🏢 Merit Medical
📍 Tijuana
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