Senior Process Engineer, Spray Drying

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%).