Engineer Sterilization

Location: Nuevo Laredo, Tamaulipas

Remote Type: On-site

Time Type: Full time

Job Description

Job Description

General Objective:

Ensure product processing, regulatory requirements, and equipment requirements are met in accordance with specifications including calibrations, internal, customer and regulatory audits, validations, record keeping and reporting for routine sterilization.

Responsabilities:

• 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.

KNOWLEDGE/EXPERIENCE       

• 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.        

SKILLS         

• Effective communication   
• Proactive   
• Able to manage multiple projects   
• Availability   
• Sense of Urgency   
• English 80%       

EDUCATION

• Bachelor Degree    

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.