0014V6022 Manufacturing Process Engineer (Pharma) / Senior Process Engineer Please contact Amanda Mazza, amanda@tworivercp.com
The ideal candidate will have a strong technical background in process design, optimization, and troubleshooting for solid oral dosage forms, including granulation, spray drying, tablet compression, and coating operations.
This role will support both day-to-day manufacturing activities and capital or process improvement projects to enhance product quality, process robustness, and operational efficiency. Provide technical support for the manufacturing of solid dosage forms, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations Lead or support process improvement and scale-up projects for granulation, spray drying, compression, and coating operations Conduct process investigations, identify root causes, and implement corrective / preventive actions to resolve manufacturing issues Develop and optimize process parameters to achieve consistent product quality and yield Prepare and review process documentation including batch records, SOPs, validation protocols / reports, and change control documents Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation Support equipment qualification and process validation activities for new or modified equipment / processes Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency Ensure compliance with all safety and regulatory requirements within the manufacturing environment QUALIFICATIONS Bachelor’s degree (or higher) in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field Minimum 3 years of hands-on experience in solid dosage form manufacturing (pharmaceutical industry required) Strong knowledge of granulation, spray drying, tablet compression, and tablet coating processes Familiarity with cGMP, FDA, and EMA regulatory requirements Excellent problem-solving, analytical, and communication skills Proven ability to work independently and in cross-functional teams within a fast-paced manufacturing environment Proficiency with process data analysis tools and process control systems preferred PREFERRED QUALIFICATIONS Experience with fluid bed granulation and / or spray drying systems Direct involvement in tablet compression and film coating process development or troubleshooting Exposure to process validation, technology transfer, and scale-up activities LOCATION On-site in Indianapolis, IN EMPLOYMENT Full-time employment preferred, open to C2C Consultant Powered by JazzHR
Manufacturing Engineer • Indianapolis, IN, US