Process Engineer

Process Engineer

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 Always" mindset.
• Attend and complete all required training to remain current with industry standards, regulatory expectations, and internal procedures.

Essential Skills

• Minimum of 3 years of experience in process engineering, preferably in the pharmaceutical or animal health industry.
• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a closely related engineering field.
• Strong analytical and problem-solving skills applied to manufacturing processes and equipment.
• Proficiency in fill-finish processes within a regulated manufacturing environment.
• In-depth understanding of process engineering principles and their application in manufacturing.
• Solid knowledge of regulatory requirements, including cGMP (current Good Manufacturing Practices) and FDA compliance expectations.
• Experience working in pharmaceutical manufacturing environments with strict quality and regulatory controls.
• Demonstrated ability to support process improvement, process engineering, and manufacturing engineering activities.
• Effective communication skills for collaborating with production, maintenance, quality, and safety teams.
• Ability to use data-driven methods to assess process performance and identify optimization opportunities.

Additional Skills & Qualifications

• Experience in the animal health or pharmaceutical industry with exposure to monoclonal or related biopharmaceutical processes.
• Experience in process improvement and continuous improvement methodologies.
• Experience supporting manufacturing processes from an engineering perspective, including troubleshooting and optimization.
• Familiarity with process safety concepts and participation in HAZOP or similar safety reviews.
• Exposure to quality management systems and change management processes…