Principal Sterilization Scientist (9)

Principal Sterilization Scientist

This is a remote position. The Principal Sterilization Scientist is responsible for developing, modifying, qualifying, validating, and implementing Ethylene Oxide (EO) sterilization processes with contract sterilizers in accordance with ISO 11135 and applicable international standards. This role serves as a technical subject matter expert for sterilization processes, microbiological and chemical testing methods, environmental monitoring programs, and contamination control strategies supporting terminally sterilized medical devices.

Key Responsibilities:

• Develop, qualify, validate, and implement EO sterilization processes in compliance with ISO 11135 and applicable regulatory requirements.
• Support sterilization process modifications, revalidations, and continuous improvement initiatives.
• Manage technical communications and activities with contract sterilizers and external laboratories.
• Support qualification and validation of microbiological and chemical methods associated with EO sterilization processes.
• Ensure compliance with ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, and ISO 10993-7 requirements.
• Interpret laboratory analyses, evaluate results against established specifications, and recommend corrective actions when necessary.
• Support environmental monitoring programs and contamination control activities for cleanroom manufacturing environments.
• Ensure compliance with ISO 14644 series standards, EN 17141, and applicable cleanroom monitoring requirements.
• Collaborate with cross-functional teams to support product development, manufacturing, quality, and regulatory initiatives.
• Support methodology transfer activities from Research & Development (R&D) to Manufacturing.
• Prepare, review, and approve validation protocols, reports, risk assessments, and technical documentation.
• Participate in investigations, root cause analyses, CAPA activities, and process improvement projects.

Required Qualifications:

• Bachelor's Degree in Microbiology, Biomedical Engineering, Chemical Engineering, Biological Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in sterilization, microbiology, validation, or related scientific/engineering roles within a regulated industry.
• Demonstrated experience with Ethylene Oxide (EO) Sterilization Process Validations.

Required Skills & Knowledge:

• EO Sterilization Validation per ISO 11135.
• Knowledge of microbiological and chemical methods supporting sterilization processes, including: ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7.
• Knowledge of environmental monitoring requirements for terminally sterilized device manufacturing.
• Familiarity with ISO 14644 Series Standards and EN 17141.
• Experience interpreting laboratory data and implementing corrective actions.
• Strong technical writing and documentation skills.
• Experience with risk assessments, investigations, CAPA, and root cause analysis.
• Ability to collaborate effectively with contract sterilizers, laboratories, and cross-functional teams.

Preferred Qualifications:

• Experience supporting terminally sterilized medical devices.
• Experience working with contract sterilization providers and external testing laboratories.
• Experience supporting methodology transfers from R&D to Manufacturing.
• Knowledge of Agile project management methodologies.
• Technical Skills: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Agile (Preferred).