Principal Sterilization Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, qualify, validate, and implement EO sterilization processes in accordance with ISO 11135 and relevant regulatory standards.

• Assist in modifications, revalidations, and initiatives for continuous improvement of sterilization processes.

• Oversee technical communications and activities with contract sterilizers and external laboratories.

• Aid in the qualification and validation of microbiological and chemical methods related to EO sterilization processes.

• Ensure adherence to ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, and ISO 10993-7 standards.

• Analyze laboratory results, assess them against established specifications, and suggest corrective actions when necessary.

• Support environmental monitoring programs and contamination control efforts within cleanroom manufacturing settings.

• Maintain compliance with ISO 14644 series standards, EN 17141, and relevant cleanroom monitoring criteria.

• Work collaboratively with cross-functional teams to bolster product development, manufacturing, quality assurance, and regulatory efforts.

• Assist in transferring methodologies from Research & Development (R&D) to Manufacturing.

• Prepare, review, and authorize validation protocols, reports, risk assessments, and technical documentation.

• Engage in investigations, root cause analyses, CAPA initiatives, and process improvement projects.

⛳️ Requirements

• Bachelor's Degree in Microbiology, Biomedical Engineering, Chemical Engineering, Biological Sciences, or a closely related scientific field.

• At least 5 years of experience in sterilization, microbiology, validation, or comparable scientific/engineering positions within a regulated environment.

• Proven experience with Ethylene Oxide (EO) Sterilization Process Validations.

• Expertise in EO Sterilization Validation in accordance with ISO 11135.

• Knowledge of microbiological and chemical methods supporting sterilization processes, including ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, and ISO 10993-7.

• Familiarity with ISO 14644 Series Standards and EN 17141.

• Experience in interpreting laboratory data and executing corrective actions.

• Strong skills in technical writing and documentation.

• Experience with risk assessments, investigations, CAPA, and root cause analysis.

• Ability to effectively collaborate with contract sterilizers, laboratories, and cross-functional teams.

🏝️ Benefits

• Professional development

• Flexible working hours