Manufacturing Process Engineer

Key Responsibilities :

• Provide technical support for solid oral dosage manufacturing (granulation, spray drying, compression, coating)
• Ensure safe, efficient, and cGMP-compliant manufacturing operations
• Lead / support process improvement, technology transfer, and scale-up projects
• Troubleshoot and resolve manufacturing issues through root cause analysis and corrective actions
• Develop and optimize process parameters for consistent quality and yield
• Prepare / review process documentation (batch records, SOPs, validation protocols / reports, change control)
• Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, Production)
• Support equipment qualification and process validation for new / modifications
• Analyze production data and recommend improvements for efficiency and performance
• Maintain compliance with safety and regulatory standards

Required Qualifications :

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field
• 5+ years hands-on solid dosage pharmaceutical manufacturing experience
• Expertise in granulation, spray drying, tablet compression, and coating
• Knowledge of cGMP, FDA, EMA regulations
• Strong problem-solving, analytical, and communication skills
• Ability to work independently and in cross-functional teams
• Proficiency with process data analysis tools / process control systems (preferred)

Preferred Qualifications :

• Experience with fluid bed granulation and / or spray drying systems
• Direct experience in tablet compression and film coating process development / troubleshooting
• Exposure to process validation, technology transfer, and scale-up activities