- 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 :
- Bachelors 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
Key Skills
Lean Manufacturing,Six Sigma,CNC Programming,Lean,Machining,Tooling,CAD,CNC,Assembly Experience,SolidWorks,Kaizen,Manufacturing
Employment Type : Full Time
Experience : years
Vacancy : 1