Sterilization Engineer

Date: 2 Feb 2024

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 9475

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Principal Responsibilities

1.    Organize and review schedules for Microbiology lab activities
2.    Release of externally sterilized loads upon receipt from contract sterilizer 
3.    Write and execute validations of equipment and processes related to sterilization, Installation, Operation Qualification (IQ, OQ), performance qualification (PQ).
4.    Perform ETO sterilization validations for products manufactured and sterilized using ETO at in-house sterilization chamber as well as at contract sterilizer facility for existing and new products
5.    Perform Gamma sterilization validation for routine and new products and microbiological laboratory equipment’s
6.    Perform validation and maintenance of steam autoclave washer disinfector 
7.    Comply with regulatory requirements, ensure adherence to procedure and maintain documentation records  
8.    Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements.
9.    Coordinate sterility testing and microbiological release for ETO sterilized products according to ISO 11135 while for Gamma according to ISO 11137.
10.    Microbiological monitoring on incoming materials, per-sterilized products, and monitor controls necessary to ensure product sterility.
11.    Monitor environmental conditions for clean room and follow up on corrective action according to ISO 14644.
12.    Support the sterilization load releases from time to time.
13.    Support cleanroom annual certification performed as per plan.
14.    Prepare annual technical reports for biological test results review.
15.    Review, update and justify microbiological test sampling plans.
16.    Review and highlight unusual trend of environmental monitoring and product bioburden testing
17.    To train and ensure lab assistants are compliance to laboratory related standard operating procedures.
18.    Support HOD on an any investigation related to environmental testing, microbiological and sterilization failures
19.    Support trainings related to contamination control plant wide
20.    Monitor nonconformance reports and trends related to environmental control, microbiological testing and sterilization.
21.    Support HOD /R&D team on product adoption sterilization validation activity.
22.    Ensure readiness for all internal and external quality audits.
23.    Ensure the microbiological laboratory audit responses are completed within determined period.
24.    Ensure the lab staffs are compliance to Good Laboratory Practices at all time.
25.    Prepare sterilization validation summary and analyze it for annual review.
26.    Perform other tasks assigned by HOD from time to time.
 

Education / Experience Requirements

Qualification    :    Degree in Biological Science or Applied Sciences or equivalent qualification

Experience    :    Computer skills in basic Microsoft Office. Good spoken and written English is essential.  
 

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.