Day Shift Sterility Assurance Engineer II — Impact & Growth

Merit Medical Systems, Inc.; Tijuana; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Cafeterias

Paid Holidays

401K

Job summary

Merit Medical Systems, Inc. in Tijuana, MX, is seeking a Sterilization Validation Specialist to write sterilization validation protocols, coordinate validations, and monitor environmental monitoring programs for cleanrooms.

You will work with contract sterilizers and laboratories, lead continuous improvement projects, and may supervise technicians. A Bachelor’s Degree in Engineering or a related technical field with five years of experience is required.

Qualifications

• Education and experience equivalent to a Bachelor's in engineering or related field, with five years of relevant work.
• Ability to apply analytical skills and scientific principles to problem solving.
• Strong computer skills: spreadsheets, word processing, database software.
• Excellent teamwork and organization; comply with international standards.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, incl. requalification and dose audits.
• Monitors environmental monitoring for cleanrooms.
• Documents product adoption into EO sterilization cycles.
• Interfaces with contract sterilizers and laboratories.
• Works independently; seeks guidance for complex issues as needed.
• May supervise technicians on the team.
• Completes investigations and dispositions of complex NCs.
• Manages compliance to Sterility Assurance and environmental metrics.
• Writes ECNs and leads continuous improvement projects.
• Oversees Environmental Monitoring programs for cleanrooms.
• Supports internal and external audits.

Skills

Analytical skills

MS Office

Team player

Interpersonal skills

Problem solving

Education

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

Tools

Spreadsheets

Word processing

Database software

ECN writing

Job description

Merit Medical Systems, Inc. in Tijuana, MX, is seeking a Sterilization Validation Specialist to write sterilization validation protocols, coordinate validations, and monitor environmental monitoring programs for cleanrooms.

You will work with contract sterilizers and laboratories, lead continuous improvement projects, and may supervise technicians. A Bachelor’s Degree in Engineering or a related technical field with five years of experience is required.