Senior Process Engineer, Spray Drying

Serán Bioscience seeks a Senior Process Engineer with expertise in spray drying manufacturing technology to aid in the commercial expansion of novel drug products. This position will serve as the technical owner of commercial spray drying systems, ensuring reliable, efficient, and compliant operation across solution preparation, spray drying, and secondary drying unit operations. This role combines hands‑on process expertise with long‑term system stewardship, driving continuous improvement, equipment reliability, and product quality.

The Senior Process Engineer, Spray Drying develops deep knowledge of equipment performance, analyzes trends to anticipate issues, and partners cross‑functionally to maintain world‑class manufacturing capability. They oversee documentation, maintenance strategies, CIP implementation, and process optimization efforts that support safe, consistent, and scalable production.

As the system owner, the engineer oversees creation and revision of equipment documentation packages, supports regulatory and client audits, and ensures alignment with cGMP expectations. They maintain a deep, data‑driven understanding of equipment performance, analyze trends to anticipate issues, and drive improvements that enhance reliability, yield, and product quality. The role collaborates closely with Maintenance, Quality, Validation, and Manufacturing to coordinate spare‑parts strategies, preventative maintenance, calibration schedules, and implementation of clean‑in‑place systems.

In a CDMO setting, the engineer also partners with clients and internal teams to support tech transfers, scale‑up activities, and lifecycle management of spray‑drying processes.

• System owner of commercial spray drying equipment, including solution preparation, spray drying, and secondary drying systems
• Assess and implement continuous improvements of spray dryer and associated unit operations
• Collaborate with other departments on strategy and schedules for spare parts, preventative maintenance, and calibration
• Collaborate with other departments on implementation and use of clean-in-place systems
• Develop and maintain knowledge base of commercial equipment performance, and analyze trends over time
• Maintain deep, data‑driven knowledge of equipment performance and analyze trends to identify risks, opportunities, and long‑term improvement strategies
• Oversee creation, revision, and lifecycle management of equipment documentation packages, including SOPs, batch records, and qualification documents
• Lead troubleshooting efforts for process deviations, equipment issues, and product quality concerns using structured problem‑solving tools
• Support scale‑up, tech transfer, and process validation activities for new and existing pharmaceutical products
• Partner with Maintenance, Calibration, and Supply Chain teams to develop strategies and schedules for spare parts, preventative maintenance, and calibration activities
• Collaborate with Quality, Validation, and Manufacturing to ensure equipment and processes meet cGMP, regulatory, and client expectations
• Work with Engineering and Operations to implement and optimize clean‑in‑place (CIP) systems for spray‑drying equipment
• Support internal and external audits, including client visits and regulatory inspections
• Contribute to technical reports, investigations, and client communications with clarity and scientific rigor
• Responsibilities may increase in scope to align with company initiatives
• Performs other related duties as assigned

• Strong understanding of spray‑drying principles, including atomization, heat/mass transfer, drying kinetics, and particle engineering
• Ability to interpret and optimize process parameters such as inlet/outlet temperatures, feed properties, airflow, and atomization settings
• Experience with commercial spray dryers, solution preparation systems, secondary drying equipment, and associated utilities
• Proficiency in analyzing process data, identifying trends, and applying statistical tools (DOE, SPC, capability analysis)
• Ability to perform mass/energy balances, process modeling, and root‑cause investigations
• Working knowledge of…