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

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

Strong interpersonal and organizational skills and the ability to work effectively as a team member.

Working knowledge of international standards as applicable to the department.

Scientific techniques/evaluation/selection/application

COMPETENCIES

Plans/surveys/structures/equipment

Special projects/ECN's/prototype creation

NCMR causes/corrective actions/dispositions

Leadership

COMMENTS
Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

#J-18808-Ljbffr

📌 Sterility Assurance Engineer II (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte