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 activities. Performs other duties as required to support the overall plant operation and quality system.

Supervision Given

Education, Experience, & Skill Required

Special Requirements

Special Requirements

Training Required

Benefits

Sotera Health offers a competitive benefits package that includes :

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics . LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor