Sterilization Assurance QA Engineer - Life Sciences

Corning Incorporated; Durham (NC); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses & incentives

Pension plan

401(k) matching

Health & wellness benefits

Paid time off

Parental leave

Job summary

Corning Incorporated in Durham, NC, is seeking a Sterilization Assurance Quality Engineer to oversee the sterility program across CLS facilities, ensuring compliance with ISO standards and regulatory requirements. You will support sterilization and aseptic processing for Life Sciences products and collaborate with Quality, Regulatory, Manufacturing, R&D, and suppliers.

The ideal candidate has a life sciences or engineering degree, 2+ years in a regulated environment, and strong data analysis and

Qualifications

• Bachelor's degree in Life Sciences, Chemistry or Engineering.
• 1–3 years related experience with sterilization, sterilization assurance, aseptic processing in a manufacturing environment.
• Working knowledge of sterilization and sterility assurance principles for medical device or life sciences products.
• Familiarity with ISO standards such as ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485.
• Experience supporting sterilization validation, dose audits, requalification, or aseptic processing activities.
• Ability to review and interpret microbiological and environmental data, validation reports, and technical documentation.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.
• Ability to work with cross-functional teams and external partners.
• Proficiency with standard business software and data analysis tools.
• Track record of delivering results.
• 2+ years’ experience in a regulated manufacturing or life sciences environment.
• Familiarity with statistical methods used in validation, sampling, and trend analysis.
• Experience supporting audits, inspections, and regulatory submissions.

Responsibilities

• Support sterilization and aseptic processing programs for Corning Life Sciences products at the Division and Site level.
• Help implement changes that improve sterilization compliance, supply flexibility, and process efficiency.
• Support product transfers to new sterilization methods, sites, or suppliers.
• Help standardize sterilization requirements such as dose ranges, SAL, and validation methods.
• Provide technical support for sterility claims for terminally sterilized and aseptically processed products.
• Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.
• Maintain knowledge of applicable standards and regulations, including ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485.
• Work with Quality, Regulatory, Manufacturing, R&D, Engineering, Supply Chain, and external partners on sterility assurance activities.
• Support sterilization and aseptic processing validations, requalification’s, and change assessments.
• Review bioburden, sterility, environmental monitoring, and other microbiological data to support sterility assurance.
• Support investigations related to sterilization, aseptic processing, contamination control, and sterility issues.
• Maintain procedures, protocols, reports, and other records related to sterilization and aseptic processing.
• Support risk assessments, audits, inspections, and training related to sterility assurance.

Skills

Sterilization principles

Data analysis

Regulatory compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Life Sciences/ Chemistry/ Engineering

Tools

ASQ Certifications

Job description

Corning Incorporated in Durham, NC, is seeking a Sterilization Assurance Quality Engineer to oversee the sterility program across CLS facilities, ensuring compliance with ISO standards and regulatory requirements. You will support sterilization and aseptic processing for Life Sciences products and collaborate with Quality, Regulatory, Manufacturing, R&D, and suppliers.

The ideal candidate has a life sciences or engineering degree, 2+ years in a regulated environment, and strong data analysis and