Sterility Assurance Engineer: Validation & Compliance

200 Merit Maquiladora Mexico, S. DE R.L. DE C.V.; Tijuana; On-site; MXN 300,000 - 500,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Medical Clinic

Onsite Cafeterias

Vacation & Holidays

Job summary

Merit Medical in Tijuana, Mexico, is seeking a Sterilization Validation/QA professional to write protocols, coordinate validations, and monitor cleanroom environmental programs. You will collaborate with contract sterilizers, document investigations, and help lead continuous improvement efforts.

The role requires a engineering/technical degree with five years’ related experience, strong analytical skills, and the ability to work as part of a team in a regulated environment.

Qualifications

• Education and/or experience equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience.
• Analytical skills and scientific technical problem solving.
• Demonstrated computer skills with spreadsheets, word processing, database software.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations and requalifications as needed.
• Monitors the environmental monitoring program for cleanrooms.
• Performs product adoptions into EO sterilization cycles using applicable standards.
• Interfaces with contract sterilizers and laboratories.
• May supervise technicians and complete investigations on NCs.

Skills

Analytical skills

Teamwork

Computer skills

Interpersonal skills

International standards

Education

Bachelor’s degree in Engineering or technical field

Tools

Spreadsheets

Word processing

Database

Job description

Merit Medical in Tijuana, Mexico, is seeking a Sterilization Validation/QA professional to write protocols, coordinate validations, and monitor cleanroom environmental programs. You will collaborate with contract sterilizers, document investigations, and help lead continuous improvement efforts.

The role requires a engineering/technical degree with five years’ related experience, strong analytical skills, and the ability to work as part of a team in a regulated environment.