Sr. Process Engineer

About the role

The Senior Process Engineer will lead process optimization and commercial manufacturing support activities for oral solid dose (OSD) pharmaceutical manufacturing processes. This role involves troubleshooting process deviations, leading root cause analyses, and driving continuous improvement initiatives.

Responsibilities

• Lead process optimization for granulation, compression, coating, and packaging operations.
• Support technology transfer 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 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.
• Mentor and support junior engineers by providing technical guidance and process expertise.

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.