Sterility Assurance Quality Engineer

Requisition Number:60973

Corning is vital to progress – in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Scope of Position:Reporting directly to the division Sterility Assurance Manager, this position involves support for the manufacturing operations and product sterility assurance, provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques across multiple manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement and Marketing) and is responsible for the quality of the product and sterility compliance to regulatory, customer and internal standards.

Day to Day Responsibilities:

• Serves as the quality representative to support multiple sterilization assurance and laboratory standardization projects within the division and applicable plants
• Schedules/coordinates/performs assigned projects, compiles test data, writes summary reports and final reports
• Provides validation support including master validation planning, change controls, protocol development, review and approvals, FAT/SAT, IQ/OQ/PQ execution/support, lead FMEAs, develop control plans, assist with documentation in electronic document management system
• 领导和支持与产品有关的活动hanges impacting sterilization equipment/processes and the associated laboratory/functional testing required as part of the validations
• Facilitates/supports investigations for product and process discrepancies and propose corrective actions to process deviations and customer complaints
• Ensures compliance to regulatory requirements related to product sterility assurance including annual product reviews, environmental controls, bioburden testing, dose audit maintenance and sterility testing

Travel Requirements:Up to 10% domestic and potentially international

Required Education:Bachelor’s degree required; prefer program in Sciences or Engineering

Required Years and Area of Experience:

• Minimum of 3+ years of quality engineering experience in a highly regulated industry; strongly prefer medical device or pharmaceutical
• Direct experience in sterility assurance or product sterilization a plus
• Experience with laboratory practices and microbiological testing methods

Required Skills:

• Strong knowledge of the regulatory and quality system requirements 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485, ISO 11137 and ISO 11737
• Experience authoring and executing validations and/ or method suitability testing
• Experience with Bio-burden/growth determination systems, aseptic methods, tissue culture techniques and sterilization systems
• Strong in application of technical principles, practices and procedures
• Leadership ability to coordinate projects at multiple locations in a multi-functional team environment
• Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication
• Knowledge of manufacturing processes and relevant statistical methods for quality assurance
• Good understanding of continuous improvement methodologies, including lean, six sigma, statistical applications and validation

Desired Experience / Qualifications / Skills:

• Experience with sterilization processes highly preferred
• Trained Six-Sigma skills, certification preferred
• ASQ Certified Quality Engineer desired

Soft Skills:

• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams
• Ability to make decisions regarding product disposition and corrective and preventive action effectiveness
• Effective communication skills at all levels both written and verbal
• Ability to perform multiple tasks and ability to effectively manage conflict
• Ability to work in teams to obtain results by effectively influencing others, self-motivated/directed, ability to organize activities

Corning Puts YOU First!

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.

• Our monetary peer-to-peer recognition program is tied to our值and celebrates you and your colleagues’ contributions.
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career.
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.
• Professional development programs help you grow and achieve your career goals.

This position does not support immigration sponsorship.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.