Overview
On Site
Full Time
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - months plu(s)
Skills
Pharma
cGMP
Process Engineer
spray drying
Job Details
- 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:
- 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
- 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:
- 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
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