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Process Improvement Engineer II

Company: OraSure Technologies
Location: Bethlehem
Posted on: August 2, 2022

Job Description:

SUMMARYResponsible for planning and leading small to medium sized projects to improve quality and efficiency of existing manufacturing processes as well as the scale-up, validation, and transfer of new products into manufacturing. Specific responsibilities will include project planning using MS Project, equipment and process design or specification, process optimization using Six Sigma or equivalent methodologies, process validation, and the implementation of process and manufacturing documentation.

ESSENTIAL DUTIES AND RESPONSIBILITIESInvestigates and implements improvements to manufacturing processes to improve quality and efficiency, ensuring that all regulatory requirements are satisfied
Review manufacturing trending reports to ensure processes remain in control, assist manufacturing in investigating processes that yield product in specification but out of control limits
Investigate non-conformance conditions and implement corrective actions
Work with Product Development teams to facilitate the successful scale-up, transfer, and validation of new products
Prepare new or modify existing procedures as necessary for product/process improvements and new product transfers
Determine Critical to Quality (CTQ) attributes of products and processes. Establish trending requirements to monitor performance of CTQ's
Design and execute engineering and validation studies for process improvements and new products
Design and execute equipment qualifications for new or improved manufacturing processesRepresent Operations on multiple new product development teams
Ensure compliance with all pertinent safety and regulatory policies
EDUCATION and/or EXPERIENCEB.S. degree in Engineering (ChemE (preferred), ME, or MfgE)
3 or more years of experience in a role responsible for process development and/or improvements for chemical or biological based products. Preferably with diagnostic assays, medical devices, or pharmaceutical products. Experience in new product development and technology transfer into manufacturing



OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.

Keywords: OraSure Technologies, Bethlehem , Process Improvement Engineer II, Engineering , Bethlehem, Pennsylvania

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