OneMain Financial Jobs

Nature and Scope The Process Engineer I is responsible for supporting manufacturing processes at all Ohio facilities in an FDA-regulated environment. This role serves as a Subject Matter Expert (SME) for process systems, manages capital projects, and ensures all process equipment and associated processes adhere to cGMP, company, local, state, and federal health, and safety requirements. Working as part of a multi-disciplinary team, the Process Engineer I manages multiple tasks simultaneously, drives projects from procurement through closure, and leads operational improvement initiatives. This hands-on position focuses on supporting equipment and processes for pharmaceutical manufacturing and packaging operations, serving both commercial and Research & Development needs. The ideal candidate possesses the ability to quickly grasp new concepts, chair meetings, present to leadership, and communicate professionally across all organizational levels. Essential Duties and Responsibilities Lead Process Utility Capital Projects Develop scope, budget, User Requirement Specifications (URS) and manage all phases of projects to completion including project close-out. Coordinate process utility support activities including equipment reconfiguration, changeover, and replacement planning Support factory acceptance testing of equipment. Maintain up-to-date drawings of new and existing equipment, systems and processes. Support preparation and maintenance of operating and preventive maintenance procedures for the process equipment to adhere to cGMP's, company, local and state requirements. Coordinate Handover of Process Utility Equipment from Engineering to Maintenance and Operations Work with engineering team to review specifications and provide input. Accept turnover packages and establish maintenance programs. Support qualification activities including protocol generation/review/execution. Support shutdown activities and scheduling process improvement work. Develop, review, revise, and maintain SOPs, operational, maintenance for all current process/packaging equipment and maintenance processes. Identify, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations in a cGMP environment. Optimize Process Utilities/PM/Repair Program Prepare and maintain operating and preventive maintenance procedures for the appropriate utilities and systems. Develop and technically review maintenance procedures. Develop and review metrics on Process Utility systems. Support shutdown activities and scheduling of PM/repair work. Evaluate breakdown statistics and adjust maintenance plans to suit. Increase utility equipment availability through reduction of breakdowns. Monitor equipment operation and implement corrective actions for out of specification operation and alarms. Support Quality Assurance investigations of process utility issues. Facilitate completion of change control documentation. Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities. Provide technical troubleshooting support to mechanics responding to breakdowns. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Required Bachelor's degree in engineering or equivalent work experience of at least 4 years. Minimum 2 years' experience in a field related to manufacturing or industrial engineering, required. Pharmaceutical manufacturing, preferred. Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's). Must be proficient in the use of Microsoft Office Applications, including Microsoft Project,