Sterility Assurance Engineer II: Validation & Compliance

Merit Medical Systems; Tijuana; Hybrid; MXN 360,000 - 480,000; Full time

Job summary

Merit Medical in Tijuana, Mexico, is seeking a Sterility Assurance Engineer II to lead sterilization validations, monitor cleanroom environments, and drive continuous improvement initiatives. You will coordinate with contract labs and sterilizers, supervise technicians, and respond to NC investigations while ensuring compliance with international standards.

Ideal candidates have a Bachelor's in Engineering or related field with several years of experience in sterility assurance and ECN

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or technical field with five years related experience.
• Apply analytical skills and scientific principles to problem solving and development.
• Proficient computer skills including spreadsheets, word processing, and databases.
• Strong interpersonal and organizational skills and the ability to work in a team.
• Working knowledge of international standards applicable to the department.
• Knowledge of scientific techniques and evaluation methods.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, including annual requalifications and dose audits.
• Monitors the environmental monitoring program for cleanrooms.
• Documents product adoptions into EO sterilization cycles using standard methods.
• Interacts with contract sterilizers and laboratories.
• May supervise technicians and oversee NC investigations and dispositions.
• Supports audits and continuous improvement projects.

Skills

Sterility Assurance

Validation

Environmental Monitoring

Problem Solving

Team Leadership

Education

Bachelor's Degree in Engineering or Technical Field

Tools

MS Excel

MS Word

Database Software

ECN Management

Job description

Merit Medical in Tijuana, Mexico, is seeking a Sterility Assurance Engineer II to lead sterilization validations, monitor cleanroom environments, and drive continuous improvement initiatives. You will coordinate with contract labs and sterilizers, supervise technicians, and respond to NC investigations while ensuring compliance with international standards.

Ideal candidates have a Bachelor's in Engineering or related field with several years of experience in sterility assurance and ECN