Sterility Assurance Engineer II

Merit Medical; Tijuana; On-site; MXN 350,000 - 550,000; Full time

Job summary

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

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 (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.

Responsibilities

• 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.

Education

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

Job description

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.