Process Engineer 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.
Duties and Responsibilities:- 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.
- Required Skills and Abilities
- 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
Education and Experience:- BS in chemical Engineering, Mechanical Engineering, or closely related discipline 7+ years (or more for Senior/Principal) hands-on spray drying experience in pharma/biotech or specialty chemicals.
- Hands-on experience with facility start-up, commissioning, and equipment qualification
- Strong knowledge of cGMP requirements and commercial manufacturing operations
Physical Requirements:
Work in lab/pilot-plant setting with solvents and fine powders; PPE required.
Ability to lift up to ~25–40 lbs occasionally; extended periods of standing during operations.
Some travel may be required for vendor FAT/SAT or client tech transfer (=10%).
