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Manufacturing Process Engineer
Manufacturing Process EngineerDcode Talent LLC • Indianapolis, Indiana, USA
Manufacturing Process Engineer

Manufacturing Process Engineer

Dcode Talent LLC • Indianapolis, Indiana, USA
17 days ago
Job type
  • Full-time
Job description
  • Role : Process / Project Engineer (Solid Dosage Form Pharmaceuticals)
  • Location : Local candidates only; hybrid work schedule
  • Sponsorship : Not available
  • 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 :

    • 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

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