We are seeking an experienced Project Validation Specialist with specialized expertise in sterilization processes and microbiological assurance to support Sterilization Workstream. This role involves managing Ethylene Oxide (EtO) sterilization validations and cycle changes, driving sterilization improvements, and ensuring compliance with regulatory standards. The ideal candidate will have a strong project management background and the ability to lead complex sterilization validation projects within the medical device manufacturing environment.

Job Title: Project Validation Specialist
Location: Anasco, PR
Duration: 12 Months

Job Responsibilities:

• Lead Ethylene Oxide (EtO) sterilization cycle validation and revalidation processes. Implement improvements for sterilization cycles and manage radiation sterilization validations and dose audit management.
• Interpret microbiological data to validate sterility, ensuring effective bioburden and endotoxin testing for sterility assurance.
• Develop and maintain comprehensive documentation, including Validation Plans, Protocols, Technical Reports, Change Controls, and SOPs, adhering to Good Documentation Practices (GDP).
• Lead sterilization workstream project governance, managing timelines and tracking progress using Microsoft Project. Provide regular updates to stakeholders.
• Assess and mitigate risks related to microbial contamination and sterility assurance, supporting remediation projects as needed.

Skills:

• In-depth knowledge of EtO sterilization validation, requalification, and radiation sterilization.
• Proficiency in creating validation protocols, change controls, and quality reports following GDP.
• Experience managing projects, tracking milestones, and using Microsoft Project.
• Strong understanding of FDA, ISO 9001, ISO 13485, and other relevant standards.
• Fully bilingual in English and Spanish.
• Ability to analyze microbiological data and interpret results effectively.

Education:

• Bachelor's degree in Engineering, Microbiology, Life Sciences, or a related field.
• Minimum 7 years of experience in medical device and/or pharmaceutical manufacturing, with preferred 15 years in sterilization validations and microbiological testing.