Validation Engineer

Job Title: Validation Engineer

Location: Fort Worth TX (Local candidates only)

Travel: Required Alabama (3 4 weeks expenses paid)

Duration: 3 6 Month Contract

Start Date: Immediate

Job Summary

We are seeking a Validation Engineer to support EO sterilization validation activities within a regulated manufacturing environment. This role will focus on supervising and coordinating Performance Qualification (PQ) execution activities while ensuring compliance with GMP and ALCOA documentation standards.

The ideal candidate will have hands-on experience with sterilization validation processes strong coordination skills and the ability to support cross-functional execution activities in a fast-paced environment.

Key Responsibilities

• Supervise execution of EO sterilization Performance Qualification (PQ) activities
• Coordinate half-cycle nominal/full-cycle and maximum-cycle sterilization runs
• Prepare and manage PCDs (Process Challenge Devices) and Biological Indicators (BIs) for shipment and cycle insertion
• Support preparation and arrangement of dunnage for EO sterilization processes
• Oversee movement of product loads through refrigerated storage tempering sterilization and aeration processes
• Coordinate retrieval and shipment of PCDs BIs and product samples for Quality Control testing
• Ensure execution activities and documentation comply with ALCOA principles and GMP requirements
• Collaborate with Validation Quality and Operations teams to support project timelines and execution

Required Qualifications

• Experience in validation within medical device pharmaceutical or regulated manufacturing environments
• Hands-on knowledge of EO sterilization validation and PQ execution activities
• Strong understanding of GMP documentation practices and ALCOA principles
• Ability to coordinate cross-functional activities and manage execution timelines
• Strong communication and organizational skills