Responsibilities:

• Assure compliance with national and international regulations and standards relevant to microbiological quality of medical devices
• Develop, write, implement, and maintain procedures for the environmental control of manufacturing areas.
• Facilitate monitoring requirements to demonstrate continued compliance with regulatory and Standards requirements.
• Oversee controlled area requirements to ensure that all aspects of programs comply with procedures / regulations.
• Be available to offer consultation to address site issues relating to microbiology for other company sites.

• Perform review of sterilization processes controlled by company.
• Lead required validation studies for continued compliance with internal procedures and regulatory requirements.
• Implement and maintain procedures for the control of sterilization clearance approval of new products or design/process changes.
• Work with Product Development team to develop sterilization validation protocols and ensure reports are documented accurately.
• Develops and maintains tracking for sterilization revalidation, quarterly dose audits and other required tracking.

Qualifications:

• A Bachelor's degree is required in Microbiology, Chemistry, or related field.
• Willingness to learn and be developed (internship experience within the medical, or closely related industry) preferred.

• Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
• Self-motivated and thrives in a fast-paced, cutting-edge environment with initiative to be proactive and seek out opportunities for improvement.
• Knowledge of ISO, guidelines, and standards for Controlled Environments/Cleanrooms
• Knowledge of cleanroom/controlled environments testing requirements and the ability to analyze related data.
• Knowledge of microbiology principles.
• Knowledge of FDA guidelines (GMP, GLP) ISO and international guidelines and standards for sterilization (EO, Irradiation, steam etc.).