Sterilization Engineer

Medline; Mexicali; Presencial; MXN 727,000 - 1,092,000; Jornada completa

Descripción de la vacante

A healthcare product company based in Mexicali, Baja California is seeking a detail-oriented individual to review sterilization records and assist in validation process setups. The role involves maintaining historical files, ensuring compliance with FDA/ISO regulations, and interacting with various departments. Ideal candidates should have a Bachelor's degree in a scientific or engineering field, proficiency in Microsoft Excel, and effective communication skills. Experience in medical device manufacturing is desirable.

Formación

• 1+ Years working in FDA/ISO 13485 regulated environment - Desirable.
• 1+ Years working in Medical Device manufacturing - Desirable.
• Must be willing to work safely in environments where hazardous materials may be present.
• English proficiency of 80%.

Responsabilidades

• Review sterilization records for completeness and accuracy.
• Assist in validation product load set up.
• Maintain sterilization related document historical files.
• Interact with individuals from different disciplines.

Conocimientos

Intermediate level skill in Microsoft Excel

Effective communication

Proactive

Able to manage multiple projects

Sense of Urgency

Educación

Bachelor's degree with a scientific or engineering background

Herramientas

SAP

AS400

Descripción del empleo

Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution.

Verification and transmittal of various biological and product samples for customers’ routine sterilization and validation loads.

Assist in validation product load set up including placement of samples and sensors within product cases and distributed throughout a load. Configure samples and product cases onto pallets according to validation study instructions and retrieve samples at designated times after processing for transmittal to laboratory.

Assist in preparation of protocols and reports for customer sterilization validations. Review test results, run records, analyze temperature and humidity data to ensure they meet the acceptance criteria of the protocol.

Configure, set-up, and download sensors used for various customer validation and equipment qualification studies. Review and ensure sensors meet calibration specifications prior to and after studies as defined in Medline procedures or customer protocols.

Maintain sterilization related document historical files by physically sorting/boxing and electronically scanning to ensure access throughout defined retention period.

Review various facility processing and maintenance documentation including process logs, equipment maintenance, equipment qualifications, and calibration records for completeness and acceptability.

Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete EO validation activities according to time sensitive schedules.

Maintain inventory and review usage logs for customer supplied biological indicators used for routine sterilization process monitoring and communicate with customers on needs.

Bachelor's degree whit a scientific or engineering background

Intermediate level skill in Microsoft Excel and Word

Intermediate level skill in Microsoft Word

1+ Years working in FDA/ISO 13485 regulated environment---Desirable

1+ Years working in Medical Device manufacturing--Desirable

Must be willing to work safely in environments where hazardous materials may be present.

Office Windows: Word, Excel, Power Point Advanced

SAP, AS400

English: 80%

Us visa requiered

Effective communication

Proactive

Able to manage multiple projects

Schedule Availability

Sense of Urgency