Regional Associate Validation Engineer

Homebased out of the Sterigenics facility in Queensbury, NY, the Regional Validation Engineer will report to the facility General Manager.

Additionally, they will be a technical representative for the Sterigenics' Director of Validations.

In that role, they will be responsible for helping to ensure the validation procedures and regulatory requirements are met and maintained for the America's region Sterigenics Ethylene Oxide facilities and its customers.

They will also provide management with information and data on all key aspects of each customer's validation project within the region, 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, EHS, Quality, Engineering and other Sterigenics' facilities, as well as customers and regulatory personnel.

Duties and Responsibilities


* Assist facilities on site/remotely in project planning and execution of facility/EAS projects to meet turn time.


* Mentor and train current and existing validation personnel in conjunction with their direct managers.


* Interface with Director of Validations to strategically plan and prioritize new and existing projects.


* Perform Root Cause Analysis / Kaizen events with facilities to promote continuous improvement.


* Writes validation protocols and final reports for the facility/EAS.


* 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.
+ Data collection and analysis of temperature and humidity data.
+ Assuring proper handling, storage and shipping of bioburden, LAL, biological indicator, or residual samples.


* 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.


* Maintains the quality and integrity of information required for validation records.


* Liaison for facility/EAS and customer activities by responding to customers' inquiries whether directly or through Quality Assurance, Customer Service Unit or Sales, to ensure prompt and accurate communication related to technical and validation issues.


* May manage/supervise the region's validation personnel.


* Performs other duties as required to support the overall regional facility operation and q...