Role: Project Validation Specialist
Location: Anasco, PR - 610
Duration: 12 Months

Position Summary:

The Senior Sterilization Validation Specialist will provide critical support to our Corporate and Division Sterilization Workstream, ensuring the efficient and timely completion of project deliverables in the sterilization area. This role involves validating new Ethylene Oxide sterilization cycles, revalidating existing cycles, and implementing cycle improvements. The incumbent will also be responsible for interpreting microbiological testing data, monitoring sterility assurance, and applying industry standards and regulations to ensure compliance.

Key Responsibilities:

• Sterilization Validation: Lead the validation and requalification of Ethylene Oxide sterilization cycles, ensuring compliance with FDA and ISO standards.
• Microbiological Data Interpretation: Work closely with site teams to interpret microbiological testing data and monitor sterility assurance in medical device manufacturing.
• Project Management: Manage sterilization-related projects independently, tracking milestones and ensuring timely completion of deliverables.
• Standards and Regulations: Interpret and apply relevant microbiology standards, including FDA, ISO 9001, ISO 13485, AAMI ST72, and others, to control programs.
• Risk Management: Understand and apply risk management principles related to microbial monitoring and sterility assurance.
• Technical Documentation: Develop and maintain technical documentation, including validation plans, protocols, SOPs, and investigation reports, in adherence to Good Documentation Practices (GDP).
• Team Collaboration: Work collaboratively in a team environment while also demonstrating the ability to conduct independent research and investigations.
• Subject Matter Expert: Serve as a subject matter expert in sterilization processes, providing guidance and insights to cross-functional teams.

Technical Skills:

• Proficient in validating sterilization processes, including Ethylene Oxide and radiation sterilization.
• Experience in conducting microbial test method validations (bioburden and endotoxin).
• Knowledge of controlled environment monitoring.
• Familiarity with applicable regulations and their interpretation within the industry.
• Proven experience in managing projects independently, with proficiency in Microsoft Project or similar software.
• Excellent organizational and communication skills, with the ability to document processes clearly and concisely.
• Bilingual: Fully bilingual in English and Spanish is preferred.

Qualifications:

• Bachelor's degree in Engineering, Microbiology, or a related discipline.
• Minimum of 12 years of experience in medical device or pharmaceutical manufacturing, with significant experience in sterilization validation and microbiological control.