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Design Assurance Engineer-CPT, Durham

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Date: Oct 23, 2021

Location: Durham, NC, US, 27712

Company: Corning

Requisition Number: 49195

 

Corning is one of the world's leading innovators in materials science, with a 166-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramics science, and optical physics, along with its deep manufacturing and engineering capabilities, to develop category-defining products that transform industries and enhance people's lives. Corning Valor™ Glass is an example of a life-changing innovation purpose-built to store and protect injectable medicines. Corning is also a global leader in pharmaceutical tubing, manufacturing a variety of clear and amber glass tubing that is converted by our customers into vials, cartridges, ampules and syringes.

 

Scope of Position:

Reporting through Design Assurance within CPT quality, this position involves direct product team support for development, commercial and manufacturing. The DA Engineer is expected to provide technical support and coordination in developing specifications, verifying product capability/reliability/function, support the development of new products and new process flow requirements, and to act as a key technical interface with CPT plant manufacturing locations and the commercial/technical community, as required, to meet internal and external requirements.

 

Day to Day Responsibilities:

• Ensure the specifications for internal/external specifications and drawings support the Corning Pharmaceutical Technologies (CPT) product value proposition and are within manufacturing capabilities.

• Review customer requests, specifications and drawings to respond to requests from the commercial team.

• Align and integrate customer product specifications with master specifications throughout business-wide processes and systems as needed.

• Prepare customer technical presentations as required.

• Collaborate with Commercial, Development and Engineering organization to establish plans to close the capability gaps.

• Use statistical software tools to determine capability as required.

• Support product and process validation in manufacturing.

• Quantify the product requirement gaps and work with Commercial, D&E or Quality, to determine if there are pathways to develop the capabilities required.

• Provide recommendations to Commercial on next steps when customer or internal quality issues require DA support. Establish processes and tools to facilitate the resolution of customer issues.

• Ensure attribute performance can achieve the customer requirements according to the committed timeline on new products and processes.

• Organize data/issues/events into formal presentations as needed.

• Support the data collection on inquiries and new specification to identify product attribute gaps and trends.

• Collect capability data on new attributes to respond to customer and internal requests.

• Create and manage risk assessments across products and processes

 

Travel Requirements: • Less than 20% initially, domestic and international

 

Hours of work/work schedule/flex-time: • Exempt position working approximately 40 hours per week, Monday to Friday, with flexibility to support project assignments and off shifts.

 

Required Education:

• Must have a minimum of a four-year Bachelor Degree in Engineering or technical field.  Preferably with a manufacturing, engineering or quality background.

 

Required Years and Area of Experience:

• Two (2) years’ experience in technology manufacturing, development or engineering environment.

 

Required Skills:

• Must be highly motivated, detail oriented, with excellent organizational and problem-solving skills.

• Working knowledge of the integration between facility documentation and manufacturing processes. Ability to implement documentation to meet business, user, and regulatory requirements.

• Must be capable of prioritizing time to handle multiple assignments and to interact with product teams.

• Knowledge of quality system documentation.

• Requires good written and oral communication skills.

• Ability to work across business functions and levels.

 

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