Sterility Assurance Engineer II: Validation & Compliance

Merit Medical; Tijuana; Vor Ort; MXN 350.000 - 550.000; Vollzeit

Zusammenfassung

Merit Medical in Tijuana, Mexico seeks a Sterilization and Microbiology professional to validate sterilization processes, perform product adoptions into EO cycles, and monitor cleanroom environmental programs. The role interfaces with external laboratories and sterilizers, guiding investigations and continuous improvement efforts.

The ideal candidate has 3–5 years in sterilization, advanced English, and strong analytical and collaborative skills to ensure regulatory compliance and high-quality

Qualifikationen

• 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 (spreadsheets, word processing, databases).
• Strong interpersonal and organizational skills and team collaboration.
• Working knowledge of international standards as applicable to the department.
• Scientific techniques/evaluation/selection/application.

Aufgaben

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations and dose audits.
• Monitors the environmental monitoring program for cleanrooms.
• Documents product adoptions into EO sterilization cycles.
• Interacts with contract sterilizers and laboratories.
• Leads standard projects with guidance on complex issues.

Ausbildung

Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry

Advanced English

Analytical skills

Interpersonal and organizational skills

Problem solving using scientific principles

Tools

Spreadsheet software

Word processing

Database familiarity

Jobbeschreibung

Merit Medical in Tijuana, Mexico seeks a Sterilization and Microbiology professional to validate sterilization processes, perform product adoptions into EO cycles, and monitor cleanroom environmental programs. The role interfaces with external laboratories and sterilizers, guiding investigations and continuous improvement efforts.

The ideal candidate has 3–5 years in sterilization, advanced English, and strong analytical and collaborative skills to ensure regulatory compliance and high-quality