What are the responsibilities and job description for the Validation Engineer position at Stark Pharma?
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
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
- 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