Sterilization Assurance Quality Engineer

Role Purpose

The Sterilization Assurance Quality Engineer is accountable and responsible for ensuring the sterility assurance program across CLS complies with specific policies, regulations and standards as they relate to sterilization or aseptic processing. They are responsible for providing support for all sterility assurance activities within CLS manufacturing facilities. Implements policies and procedures at all of CLS locations relating to Quality consistent with the Sterilization Center of Excellence (SCOE), Divisional, and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements. This position reports to the Sterilization Assurance Program Lead.

Key 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.

Experiences/Education - Required

• 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 applicable 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.
• Able to work effectively with cross-functional teams and external suppliers or laboratories.
• Proficiency with standard business software and data analysis tools.

Experiences/Education - Desired

• 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.
• Ability to assess the impact of product, packaging, or process changes on sterility assurance.
• Strong problem-solving and technical investigation skills.
• ASQ Certifications (CQA / CQE / CMQOE) preferred.
• Works well with cross-functional teams.
• Communicates clearly with technical and non-technical audiences.
• Uses good judgment to solve technical and compliance issues.
• Manages multiple tasks and deadlines effectively.
• Pays close attention to detail.
• Identifies problems and helps drive solutions.
• Adapts well to changing business and regulatory needs.
• Works independently and as part of a team.
• Maintains clear documentation and follows through on actions.
• Focuses on customer needs, product quality, and compliance.

Reward and Benefits

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well.
• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
• We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.