Sr. Process Engineer

Syner-G • Wilmington, DE

1d • Remote

About The Position

Syner-G is seeking a Senior Process Engineer with 8+ years of experience in oral solid dose (OSD) pharmaceutical manufacturing to lead process optimization and commercial manufacturing support activities. This role is centered on improving and sustaining robust OSD processes across granulation, compression, coating, and packaging operations. The Senior Process Engineer will support technology transfer from development to commercial manufacturing, troubleshoot complex process and yield issues, and provide technical leadership during PPQ and continued process verification activities. Acting as a key technical partner to MSAT, Manufacturing, QA, and Engineering, this individual will drive process robustness, efficiency, and compliance across client programs.

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.
• Proven ability to collaborate in cross-functional GMP environments.
• Strong knowledge of GMP requirements and pharmaceutical manufacturing regulations.
• Solid understanding of OSD unit operations, process controls, and equipment capabilities.
• Experience investigating deviations, leading root cause analyses, and implementing corrective and preventive actions.
• Strong communication skills and the ability to serve as a technical lead across functions.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

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, ensuring process scalability, robustness, and reproducibility.
• Troubleshoot process deviations, yield losses, equipment challenges, and cycle time constraints in commercial OSD manufacturing environments.
• Provide technical support for process validation activities, including PPQ execution and continued process verification.
• Collaborate closely with MSAT, Manufacturing, Quality, and Engineering teams to resolve technical issues and implement sustainable process improvements.
• Develop and maintain process documentation such as process descriptions, equipment specifications, risk assessments, and technical reports.
• Conduct data analysis and performance trending to identify root causes, variability drivers, 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 and process expertise.

Benefits

• We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work almost anywhere. If a physical location is preferred, office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level