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