Job Summary:

Integra is seeking an experienced Project Validation Specialist III with expertise in sterilization processes and validation. This senior-level professional will support Corporate/Division Sterilization Workstreams, ensuring the timely and efficient completion of project deliverables. The ideal candidate has a strong background in sterilization validations, project management, and communication, with at least 15 years of relevant experience.

Key Responsibilities:

• Provide subject matter expertise (SME) in sterilization, including ethylene oxide (EO) sterilization cycle validation, re-validation, and improvement initiatives.
• Collaborate with sites to interpret microbiological testing data and maintain sterility assurance in medical device manufacturing.
• Apply standards and regulations to microbiological and sterility assurance control programs, interpreting data and implementing necessary procedures.
• Conduct microbial test method validations, manage associated projects, and implement remediation plans.
• Develop and revise technical documentation, including change controls, validation plans, validation protocols, technical reports, SOPs, and other essential records.
• Monitor and validate bacterial endotoxin and bioburden testing methods, as well as controlled environment monitoring.
• Manage radiation sterilization validation and dose audits, ensuring compliance with regulatory and industry standards.
• Utilize project management skills to track milestones and ensure successful project execution.

Qualifications and Skills:

Required Expertise:

• Sterilization Validation:
  • Ethylene Oxide sterilization (validation and requalification).
  • Radiation sterilization validation and dose audit management.
  • Bacterial endotoxin and bioburden test method validation and monitoring.
• Regulations & Standards:
  • In-depth knowledge of FDA, ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, European Medical Device Regulation, and USP standards.
• Documentation & Reporting:
  • Excellent technical writing skills with a strong understanding of Good Documentation Practices (GDP).
  • Experience creating and revising procedures for microbiological monitoring in operations.

Other Skills:

• Advanced project management skills, including proficiency with Microsoft Project.
• Strong organizational and communication abilities.
• Results-oriented mindset with a focus on quality and compliance.
• Fully bilingual in English and Spanish.

Education and Experience:

• Education: Bachelor's degree in engineering, microbiology, or a related discipline.
• Experience: Minimum of 7 years in medical device and/or pharmaceutical manufacturing with effective sterilization process experience.

Preferred Attributes:

• Experience with reusable medical devices and controlled environment monitoring.
• Proven ability to lead projects independently and collaborate within cross-functional teams.
• Demonstrated capability in risk management related to microbial monitoring and sterility assurance.