Senior Process Engineer, Spray Drying

Serán is seeking a hands-on Process Engineer with deep spray drying expertise to develop, scale, and transfer robust processes for small molecule and complex drug products. You will lead end-to-end unit operations—from feasibility and DOE through clinical/commercial scale-up—while ensuring safety, quality (GMP), and operational excellence in a fast-paced, collaborative environment.

 

As the system owner, the Process 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

Oversee creation of and revisions of equipment documentation packages

• Assess and implement continuous improvements of spray dryer and associated unit operations driving reduced cycle times, increase yields, improve consistency; lead root cause analyses and FMEAs.
• Collaborate with other departments on strategy and schedules for spare parts, preventative maintenance, calibration, and commissioning/qualification.
• 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
• Design and execute DOEs/QbD studies to define CPPs/CMAs and establish robust, scalable design spaces.
• Data analysis & documentation: write protocols/reports; maintain complete technical records; present findings to clients and internal stakeholders.
• Cross-functional collaboration with Formulation, Analytical, QA/RA, Manufacturing, and Facilities; provide SME support during batch execution and deviations/CAPAs.
• Safety & compliance: champion process safety (PHA, solvent handling, inerting), and ensure GMP alignment in development and clinical manufacturing.

Expertise with common unit operations for spray drying, including solution preparation and secondary drying

Demonstrated experience working in and supporting GMP manufacturing lines

Demonstrated experience with principles of risk-based decision making and common tools for risk analysis

Ability to apply rigorous scientific and engineering principles to guide practical decisions

Working knowledge of process thermodynamics, fluid mechanics, and heat and mass transfer

Ability to analyze complex data sets

Excellent verbal and written communication skills

Ability to collaborate effectively with stakeholders across the organization

Excellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlines

Ability to function in a fast-paced team environment