Process Improvement Engineer I

Job description

OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market. Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions. It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. **Overview** Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease. Support projects to improve the quality and efficiency of existing manufacturing processes as well as the scale-up, validation, and transfer of new products into manufacturing. ### Snapshot of Responsibilities: - Support the investigation and implementation of 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. - Support the development and execution of engineering and validation studies for process improvements and new products. - Support the development and execution of qualifications for new or improved manufacturing processes. - Ensure compliance with all pertinent safety and regulatory policies. ### What you bring: - B.S. degree in Engineering (ChemE (preferred), ME, or MfgE) - 1-2 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 preferred. - Well-developed knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, OneDrive, and Teams. - Basic knowledge of Good Manufacturing Practices in a regulated industry preferred - Demonstrated technical skill and experience in process validation and equipment qualification preferred. - Good analytical and problem solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis. Six Sigma certification is a plus. - Good communication skills, written and oral. Must be capable of giving and following written and oral directions. - Technical writing skills including experience writing manufacturing documentation (Batch Records, Material Specs, Bills of Material, etc) preferred. - Mechanical design proficiency using SolidWorks or equivalent 3D CAD system a plus. - Experience as a project manager/planner, preferably using MS Project is a plus. - Previous experience leading process improvement/new product transfer projects is a plus Experience with SAP or other similar ERP system is a plus. - This role may include standing or sitting for extended periods, manipulating laboratory equipment, handling delicate instruments, and performing precise manual tasks. The role may involve the use of personal protective equipment (PPE) such as gloves, safety goggles, and lab coats. Additionally, employees in the role should expect occasional lifting, carrying, and transporting of laboratory materials (up to 25 pounds), as well as working with potentially hazardous substances following strict safety protocols. - Travel may be required to support local Bethlehem, PA sites within a 10-mile radius. Additional limited travel upon request may be required for training, audits, or collaboration with other company locations or external partners.