Sterility Assurance QA Engineer (Life Sciences)

Corning Incorporated; North Carolina; On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses and long-term incentives

Company-paid pension

Health benefits and PTO

Job summary

Corning Incorporated is seeking a Sterilization Assurance Quality Engineer to steward the sterility assurance program across CLS facilities. You will support aseptic processing, implement compliance improvements, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners on sterility activities.

The role requires a Bachelor’s degree in life sciences/engineering and 1–3 years in sterilization, with familiarity of ISO standards.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry or Engineering or related field of study.
• 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 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.

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

Communication skills

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Chemistry or Engineering

Tools

Data analysis tools

Job description

Corning Incorporated is seeking a Sterilization Assurance Quality Engineer to steward the sterility assurance program across CLS facilities. You will support aseptic processing, implement compliance improvements, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners on sterility activities.

The role requires a Bachelor’s degree in life sciences/engineering and 1–3 years in sterilization, with familiarity of ISO standards.