Sterility Assurance 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

Benefits package

Job summary

Corning Incorporated in Durham, NC seeks a Sterilization Assurance Quality Engineer to ensure the sterility assurance program across CLS. You will support sterilization and aseptic processing activities, standardize dose ranges and validation methods, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners to ensure regulatory compliance.

The role requires a Bachelor’s degree in Life Sciences, Chemistry or Engineering and 1–3 years in sterilization/aseptic processing,

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry or Engineering or related field.
• 1-3 years related experience with sterilization and aseptic processing in a manufacturing environment.
• Working knowledge of sterilization and sterility assurance principles for medical device or life sciences products.
• Familiarity with ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, ISO 13485.
• Experience supporting sterilization validation, dose audits, requalification, or aseptic processing activities.

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, requalifications, 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 knowledge

Aseptic processing

Data interpretation

Quality systems

Education

Bachelor’s degree in Life Sciences, Chemistry or Engineering

Job description

Corning Incorporated in Durham, NC seeks a Sterilization Assurance Quality Engineer to ensure the sterility assurance program across CLS. You will support sterilization and aseptic processing activities, standardize dose ranges and validation methods, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners to ensure regulatory compliance.

The role requires a Bachelor’s degree in Life Sciences, Chemistry or Engineering and 1–3 years in sterilization/aseptic processing,