Principal Sterilization Scientist

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🕒 June 14

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MG Staffing Group

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

MG Staffing Group is a recruitment agency specializing in staffing for the STEM (Science, Technology, Engineering, and Manufacturing) industries. They are dedicated to connecting qualified candidates with companies looking for skilled professionals in these critical sectors.

📋 Description

• 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.

🎯 Requirements

• 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. • 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. • 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.

🏖️ Benefits

• Professional development • Flexible working hours