Process Validation Specialist (ETO)

QRC Group, LLC • Caguas, PR

2d

About The Position

Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products.

Requirements

• Bachelor Degree Engineering (Industrial, Chemical, Biomedical), Microbiology, Sciences, or related fields)
• 4 years of experience in process validation (ETO)
• Strong understanding of EtO sterilization processes and critical parameters (humidity, temperature, concentration, exposure time).
• Solid knowledge of microbiology applied to sterilization.
• Proficiency with statistical analysis tools (Minitab, JMP, etc.).
• Experience in process validation within regulated environments.
• Familiarity with quality management systems (QMS).
• Ability to interpret international standards and regulatory requirements.

Responsibilities

• Develop, execute, and document IQ/OQ/PQ validation protocols for EtO sterilization processes.
• Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations.
• Analyze microbiological, physicochemical, and process performance data.
• Ensure compliance with applicable standards such as ISO 11135, ISO 10993-7, ISO 13485, and FDA/EMA regulations.
• Manage process changes through impact assessments and revalidations.
• Prepare technical reports, scientific justifications, and supporting documentation for internal and external audits.
• Collaborate with Quality, Engineering, Manufacturing, and Supplier teams to resolve deviations or nonconformities.
• Participate in continuous improvement initiatives, process optimization, and reduction of EtO residuals.
• Maintain and update standard operating procedures (SOPs) related to sterilization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level