Process Improvement Engineer II
Company: OraSure Technologies
Location: Bethlehem
Posted on: July 31, 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 satisfiedReview manufacturing trending reports to ensure
processes remain in control, assist manufacturing in investigating
processes that yield product in specification but out of control
limitsInvestigate non-conformance conditions and implement
corrective actionsWork with Product Development teams to facilitate
the successful scale-up, transfer, and validation of new
productsPrepare new or modify existing procedures as necessary for
product/process improvements and new product transfersDetermine
Critical to Quality (CTQ) attributes of products and processes.
Establish trending requirements to monitor performance of
CTQ'sDesign and execute engineering and validation studies for
process improvements and new productsDesign and execute equipment
qualifications for new or improved manufacturing processesRepresent
Operations on multiple new product development teamsEnsure
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
manufacturingOraSure 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
Click
here to apply!
|