Process Improvement Engineer I

• 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.
• 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.

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.