Job Description

Requisition Number: 45426

Corning is one of the worlds 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 peoples 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, Cornings 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.

Brief Description of Role:

* Provide solid technical skill and engineering support for design and development activities for new and existing products
* Coordinates project design, cost estimates, schedule, interface with vendors, etc. on development projects.
* Manage and verify requirements; capture detailed descriptions of system capability and functionality; and ensure the project team has clear, consistent, and testable requirements documented in test plans, test procedures, and completion criteria
* Review and harden requirements with customer representatives
* Develop and maintain the Requirements Verification Traceability Matrix (RVTM)
* Coordinate with the Test Engineers to align testing priorities with the business needs and confirmed requirements.
* Support the Change Control processes and Engineering Review Boards to ensure that the appropriate categorization and disposition of all requirements.
* Reconcile conflicts; decompose high-level information into the appropriate level of detail for team members; and participate in peer reviews of requirements documentation.
* Collaborate with vendors on sub system requirements and deliverable timelines
* Provide weekly status updates to management.

Minimum Qualifications

Education:

* Bachelor's degree in either; BioEngineering, Mechanical Engineering, Chemical Engineering or Plastics Engineering.

Experience:

* 5 years experience as project engineer relevant experience in Bioprocessing, Pharma, or related Biotechnology field of work.
* Experience working with suppliers, end users and stakeholders in a systems integration and test environment for the implementation, testing, and transition of a production capability.
* Experience working with Test Engineers in the creation and implementation of complex detailed test plans to ensure requirements traceability that lead to a favorable customer acceptance of delivered equipment and integrated systems.
* Demonstrated ability in leading projects/activities to meet customer requirements
* Demonstrated ability to create and manage a Requirements Verification Traceability Matrix (RVTM) and 5 years of experience with Requirements Management.
* Thorough knowledge of requirements management processes, procedures, and resources to include understanding of related test processes, test procedures, and test infrastructures.
* Ability to analyze and assess requirements
* Understanding of standard Change Management process
* Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Project and Outlook)
* Strong verbal and written communication skills
* Strong qualitative skills and quantitative skills.
* Ability to work independently with minimal supervision
* Ability to multi-task
* Work well under pressure

Preferred Qualifications:

* Electro-mechanical systems experience, programmable industrial controls, PLCs, process control
* Experience with Verification and Validation
* Knowledge of IQ/OQ/PQ
* Experience performing Requirements Management in hardware and software systems / industrial systems.
* Experience in CAD systems; SolidWorks, Pro/ENGINEER or CREO using PDM/PLM systems.
* Strong experience in plastic part design and GD&T per ASME Y14.5 standards.
* Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
* Knowledge of biocompatible material selection for sterile single-use applications in bioprocessing and/or medical device applications.
* Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
* Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.

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, or 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: Boston