Manufacturing Process Engineer
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
- 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
- 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
