Process Engineer

Key Responsibilities

• Provide engineering support for manufacturing operations, equipment reliability, and process performance.
• Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Lead continuous improvement initiatives focused on process optimization, yield improvement, waste reduction, and operational efficiency.
• Support capital projects involving manufacturing equipment, facility upgrades, automation, and control systems.
• Partner with Production, Quality, Safety, Maintenance, and Engineering teams to resolve operational challenges.
• Develop and implement process performance metrics and monitoring tools.
• Support validation, change control (MOC), and process qualification activities.
• Work with vendors, contractors, and cross-functional stakeholders to implement process improvements.
• Analyze manufacturing data and recommend solutions to improve equipment uptime and product quality.
• Assist with new product introductions, technology transfers, and manufacturing scale-up activities.
• Ensure compliance with cGMP, FDA, safety, environmental, and quality requirements.

Qualifications

• Bachelor's Degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related Engineering discipline.
• 5+ years of Process Engineering experience within a pharmaceutical, chemical, biotechnology, or other regulated manufacturing environment.
• Experience supporting manufacturing operations, process improvements, and troubleshooting production issues.
• Knowledge of cGMP regulations and regulated manufacturing practices.
• Experience performing root cause investigations and implementing corrective actions.
• Strong analytical, problem-solving, and communication skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint.