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Sr. Process Engineer (Sterilization)

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Date: Sep 5, 2021

Location: Durham, NC, US, 27712

Company: Corning

Requisition Number: 47985

 

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

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 ROLE: Leads process development initiatives to improve existing products and manufacturing processes and introduce new manufacturing and engineering processes to the Durham, NC, manufacturing site. Develop and integrate new technologies into the manufacturing environment for sterilization, labware, and cell culture. Support the daily response to operational upsets and champion long-term solutions and systems improvements to enhance the safety, quality, productivity, and reliability of manufacturing systems. Leads capital and non-capital projects from concept through implementation including determining project scope and resource needs, establishing mold and equipment specifications, completing FATs and DOEs, and writing and executing validation protocols and project plans. Actively support, improve, and ensure compliance to the site business and quality management systems through documentation preparation, process auditing, and completion of corrective actions in response to customer complaints and audit findings. This position works closely with operations management, functional leaders, engineers, and external partners to establish work priorities and work assignments across the various functional groups.

Day to Day Responsibilities:

  • Manufacturing Support: Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations.
  • Work with Operations to gather support need information and provide updates on process status.
  • Quickly respond to production and process upsets, solve 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).

Technical Leadership:

  • Provide technical leadership in assigned processes, including sterilization, labware, and cell culture areas. Act to continuously improve and expand the site’s core process capabilities and overall plant performance through project identification and completion.
  • Use of engineering principles to drive mechanistic understanding and root cause identifications
  • Lead standardization efforts in assigned processes. Look for standardized approaches for machine designs or work processes to maximize plant standardization, operational efficiency, and future project efficiencies.
  • Ensure alignment by all site functional groups to standard processes, business and quality systems, and governmental regulations (OSHA, ISO, QSR, FDA, GMP, etc.).
  • Identify and implement modifications to production equipment and processes to improve overall equipment efficiency (OEE) by improving process yield, improving production rate, and improving machine availability. 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.

Process Development:

  • Gain process expertise through training and experimentation then apply process expertise to develop robust manufacturing systems.
  • Develop robust processes & architectures via use of tools such as PQA & Six sigma • Use Six Sigma tools for, process capability studies, statistical process control determination, measurement systems analysis, and development of process controls systems.
  • Act to continually improve operations processes through projects, experimentation, designs, and process enhancements. Plan, specify, and implement process improvements, machine modifications and tooling improvements. • Process Validation and Quality Systems Responsibilities:
  • Validate production processes as needed using site validation processes. Establish and implement validation master plans and document validation results. Identify processes operating outside of validated state through production audits and take corrective actions to return processes to normal operation.
  • Closely adhere to requirements of the plant quality systems including compliance to the change control procedure when introducing or modifying manufacturing processes and equipment.
  • Ensure compliance of business and quality systems in manufacturing, i.e. OSHA, ISO9001, ISO13485, QSR CFR 21 part 820, GMP, etc. through audits against documented procedures.
  • Take corrective action when audits identify any non-conforming process.

Travel Requirements:

  • Limited project or training related.

Hours of work/work schedule/flex-time:

  • Standard business hours: Monday – Friday.
  • This position supports a 24/7 manufacturing operation; ability to support on-call rotation to resolve off-hours manufacturing process upsets or plant systems downtime events.

Minimum Requirements:

  • Bachelor’s degree in Engineering, Material Science, Physics, Physical Science or other related science degree program (Biology, Microbiology, Chemistry).
  • Minimum of 6+ years’ experience in an engineering or technical role in a manufacturing or R&D environment.  Military experience considered.
  • Ability to lead process engineering and validation projects.
  • Creative / innovative problem solving.
     

Desired Experience / Qualifications / Skills:

  • Strong preference for process expertise in sterilization. Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies.
  • Master’s degree.
  • Knowledge of injection molding, extrusion, and packaging equipment.
  • Project leadership skills.
  • Six Sigma trained.
  • OSHA, FDA, ISO, cGMP knowledge.
  • Experience running process validations.
  • Familiarity with engineering tools and approaches: DOE, SPC, Data Analysis, DMAIC, KT, etc.
  • Ability to collaborate across functional departments and able to lead and work in a team environment to solve problems and drive project work forward.
  • Technical curiosity and willingness to learn.

 

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.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh