Sterilization Assurance Quality Engineer

Corning•Tewksbury, MA

9d•$67,237 - $92,451

About The Position

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.

Requirements

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
Ability to work effectively with cross-functional teams and external suppliers or laboratories
Proficiency with standard business software and data analysis tools
TRAINING ALIGNED WITH MANUFACTURING & ENGINEERING INSTITUTE LEARNING JOURNEY
Track record of delivering results
Demonstrated knowledge in a technical field
Project team membership

Nice To Haves

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

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.