Sterilization Assurance QA Engineer — Life Sciences Impact

Corning Incorporated; Tewksbury (MA); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses and incentives

401(k) plan

Health benefits

Parental leave

Job summary

Corning in Durham, NC seeks a Sterilization Assurance Quality Engineer to lead our sterility programs across CLS facilities. You will implement SCOE-aligned policies, review data, support validations, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners.

Ideal candidates hold a Life Sciences/Engineering degree with 1–3 years of sterilization experience, knowledge of ISO standards, and strong problem-solving and communication skills. Travel ~5-10%.

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.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.
• Strong written and verbal communication skills.

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 knowledge

Aseptic processing

Quality systems

Data analysis

Cross-functional teamwork

Education

Bachelor’s degree in Life Sciences/Engineering

Job description

Corning in Durham, NC seeks a Sterilization Assurance Quality Engineer to lead our sterility programs across CLS facilities. You will implement SCOE-aligned policies, review data, support validations, and collaborate with Quality, Regulatory, Manufacturing, R&D, and external partners.

Ideal candidates hold a Life Sciences/Engineering degree with 1–3 years of sterilization experience, knowledge of ISO standards, and strong problem-solving and communication skills. Travel ~5-10%.