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Posted 11 hours ago
Senior Process Engineer
Syner-GSr. Process Engineer
Requirements
BS or MS in Chemical Engineering or related field, 8+ years OSD pharmaceutical manufacturing experience, Experience with tablet presses and granulators, Knowledge of GMP regulations
Skills
ManufacturingProcess EngineeringGMP
About the role
Responsibilities
- Lead process optimization for oral solid dose manufacturing processes, including granulation, compression, coating, and packaging
- Support technology transfer activities from development and pilot operations into commercial manufacturing
- Troubleshoot process deviations, yield losses, equipment challenges, and cycle time constraints
- Provide technical support for process validation activities, including PPQ execution and continued process verification
- Collaborate with MSAT, Manufacturing, Quality, and Engineering teams to resolve technical issues
- Develop and maintain process documentation such as process descriptions, equipment specifications, and risk assessments
- Conduct data analysis and performance trending to identify root causes and improvement opportunities
- Support commissioning, qualification, and start-up activities for OSD manufacturing equipment
- Drive continuous improvement initiatives focused on throughput, yield, cost reduction, and GMP compliance
- Mentor and support junior engineers by providing technical guidance
Requirements
- BS or MS in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical field
- 8+ years of experience in oral solid dose pharmaceutical manufacturing
- Hands-on experience with tablet presses, granulators, fluid bed systems, and coating equipment
- Demonstrated experience supporting tech transfer and commercial manufacturing operations
- Direct involvement in PPQ, continued process verification, and commercial process support
- Strong knowledge of GMP requirements and pharmaceutical manufacturing regulations
- Experience investigating deviations and leading root cause analyses
About the Company
Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients. Recognized as a "Best Place to Work," Syner-G fosters a culture of growth, innovation, and meaningful real-world outcomes.
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Syner-G · Newark
