Sterilization Assurance QA Engineer – Life Sciences Impact

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

Benefits offered by this job

Company-wide bonuses and long-term/in센

100% company-paid pension

Health and well-being benefits

Paid parental leave

Life insurance

Job summary

Corning Incorporated in Durham, NC is seeking a Sterilization Assurance Quality Engineer to ensure the sterility program across CLS complies with policies and regulatory standards. You will support aseptic processing, sterilization validations, and risk assessments.

The role involves collaborating with Quality, Regulatory, Manufacturing, R&D, Engineering, and Supply Chain to standardize dose ranges, SAL, and validation methods, and to review microbiological data and validation reports.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry or Engineering.
• 1-3 years sterilization, sterilization assurance or aseptic processing experience in manufacturing.
• Working knowledge of sterilization and sterility assurance for life sciences products
• Familiarity with 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 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; detail-oriented
• Cross-functional collaboration with Quality, Regulatory, Manufacturing, R&D, Engineering, Supply Chain
• Proficiency with standard business software and data analysis tools

Responsibilities

• Support sterilization and aseptic processing programs for CLS 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

Aseptic processing

Regulatory compliance

Quality systems

Data analysis

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in Life Sciences, Chemistry or Engineering

Tools

MS Office

Data analysis tools

Job description

Corning Incorporated in Durham, NC is seeking a Sterilization Assurance Quality Engineer to ensure the sterility program across CLS complies with policies and regulatory standards. You will support aseptic processing, sterilization validations, and risk assessments.

The role involves collaborating with Quality, Regulatory, Manufacturing, R&D, Engineering, and Supply Chain to standardize dose ranges, SAL, and validation methods, and to review microbiological data and validation reports.