Process Engineer

Job Title:

Process Engineer Job Description This Process Engineer role provides hands-on technical support for manufacturing operations, ensuring that process equipment and systems operate in a state of control and in full compliance with cGMP and regulatory requirements. You will troubleshoot complex process and equipment issues, support maintenance activities, and drive data-based improvements to enhance performance, capacity, and reliability. This position offers exposure to pharmaceutical and animal health manufacturing processes, including fill-finish operations, within a leading, highly regulated production environment. Responsibilities + Provide technical support and engineering solutions for process and equipment-related issues, including real-time support for production staff during manufacturing activities. + Support maintenance activities by providing technical guidance and assisting in troubleshooting complex equipment and process problems. + Understand the basis for qualification of equipment and ensure that all equipment and systems remain appropriate and fit for their intended purpose. + Ensure equipment and processes operate in a consistent, expected state of control and remain aligned with regulatory commitments, cGMP requirements, and relevant standards. + Provide on-floor support to Manufacturing teams to troubleshoot equipment and process issues, ensuring all issues are captured in the quality management system. + Lead or support root cause analyses for process and equipment deviations, and ensure appropriate corrective and preventive actions are identified, implemented, and documented. + Oversee changes, maintenance, and other interventions to ensure they do not negatively impact the qualified state of equipment or processes. + Document all changes and interventions appropriately through the established change management system. + Use data-driven analysis to evaluate process and equipment performance and capacity, and identify, recommend, and implement improvements to optimize system performance. + Ensure all process operations comply with health, safety, and environmental policies and procedures. + Participate in HAZOP and process safety reviews, identifying and helping to mitigate hazards associated with manufacturing processes and equipment. + Demonstrate strict adherence to local, state, and federal requirements, cGMP standards, and internal policies and procedures, consistently promoting a "Safety First and Quality To view full details and how to apply, please login or create a Job Seeker account