Associate Validation Engineer

Overview

Associate Validation Engineer at Sterigenics reports to the Quality Assurance (QA) Manager. The role provides leadership and data for all customer validation projects and interfaces with cross-functional teams, customers, and regulatory agencies.

Responsibilities

• Plan, organize, and coordinate customer validation activities at the facility.
• Write validation protocols and final reports supplied by the facility.
• Review and approve customer or consultant supplied protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
• Execute validation protocols and technically driven customer projects, including scheduling project runs, ancillary resources, lab testing, sample handling, cycle programming, process documents, safety assessments, microbiological sampling, temperature / humidity probe data collection, and proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples.
• Assure that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
• Provide support to Maintenance or Engineering in the performance of IQ / OQ / PQ activities of new or existing facility equipment and annual equipment re-commissioning (sterilization and laboratory).
• Update validation status in the relevant systems and assist with corrective action and validation process improvement activities.

Qualifications

Special Requirements

Training Required

Must complete all required training for validation internal certification.

Benefits

EEO Statement

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 U.S. 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.

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