Associate Validation Engineer

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Associate Validation Engineer

Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, Associate Validation Engineer will provide management with information and data on all key aspects of each customer’s validation project, which is used by both the plant and the customer to determine the course of routine processing.

Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory (if any), EHS, Quality, Engineering and other Sterigenics’ facilities, as well as customers and regulatory personnel.

Duties and Responsibilities


* Plans, organizes, and coordinates customer validation activities at the facility.


* Writes validation protocols and final reports supplied by the facility.


* Reviews and approves customer or consultant supplied validation or test protocols for execution within the limitation of the facility’s equipment and Sterigenics operating procedures and compliance with current regulatory standards.


* Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
+ Scheduling the project runs, ancillary resources, lab testing and sample handling.
+ Cycle programming and preparation of necessary process documents and safety assessments.
+ Microbiological samples
+ Data collection and analysis of temperature and humidity probe data 
+ Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory


* Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST. 


* Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment. 


* Responsible for annual equipment re-commissioning (sterilization and laboratory). 


* Update validation status in the relevant systems. 


* May be required to assist with corrective action and validation process improvement activit...