Sterilization Process Engineer

Corning

  • Durham, NC
  • $79,997-109,996 per year
  • Permanent
  • Full-time
  • 1 month ago
Requisition Number: 62584Corning 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: In this role, you will be responsible for supporting Corning's sterilization technology and terminal sterilization processes across the CLS division. We look for you to support of development, engineering, and manufacturing projects. You will need to collaborate with cross-functional teams including but not limited to Operations, Quality, Engineering, and Division Engineering. Primary responsibility will be support of internal sterilization equipment, process, and technology as well as interface with outside vendors.Day to Day Responsibilities:
  • Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations
  • Work with operations to gather support needed, information, and provide updates on process status
  • Quickly respond to production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations
  • Work with operations to further develop SPC/SQC for process discipline and control (PD/PC)
  • Provides technical leadership in assigned processes and escalate issues appropriately
  • Act to continuously improve and expand the core process capabilities
  • Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications
  • Responsible for providing technical expertise and strategic direction for sterilization
  • Supporting and executing activities related to development, validation, routine sterilization and requalification activities
  • Lead and work collaboratively across project teams as assigned, which may include commercial product support, continuous improvement activities, innovation projects, or other activities related to sterilization
  • Reviewing and analyzing process data for trends and improvement areas
  • Monitor internal asset performance with focus to 98% uptime
  • Documents changes via the change control process
  • Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality
  • Provide indirect leadership to assigned technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals
Travel Requirements: Up to 5% domestic, potential for international in the futureHours of work/work schedule/flex-time: Onsite standard business hours; Monday - Friday; off hours depending upon project or to resolve process upsets or system downtime events (rotating coverage schedule)Required Education: Minimum Bachelor's degree in engineering, material science, physics, physical science or other related science degree programRequired Years and Area of Experience:
  • 5+ years experience in engineering or manufacturing environments
  • Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies
Required Skills:
  • Broad knowledge of sterilization techniques and fundamentals
  • Creative/innovative problem solving
  • Able to collaborate across organizational boundaries and integrate solutions
  • Strong experimental practices and engineering problem solving; can understand fundamentals and recognize deviations and implement routine solutions
  • Proficient in the use of software programs such as MS Word, Excel, PowerPoint
Desired Experience / Qualifications / Skills:
  • Prior experience with sterilization technology and/or sterilization methods
  • Experience within the Life Sciences or medical device industries
  • Medical device quality systems and sterility assurance requirements
  • DMAIC and/or lean manufacturing principles
  • Equipment and product design and validation experience
  • Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
  • Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation
  • Experience working with data analysis software (JMP, Minitab, etc.)
This position does not support immigration sponsorship.The range for this position is $79,997.00 - $109,996.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.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
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.
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. To request an accommodation, please contact us at .

Corning