Senior Process Engineer, Spray Drying

Seranbio; Bend (OR); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Life and disability insurance

Employee assistance program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon seeks 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 to clinical/commercial scale‑up—ensuring safety, quality, and operational excellence in a fast-paced, collaborative environment.

As system owner, you will oversee documentation, audits, and compliance, while partnering with Maintenance, Quality,

Qualifications

• BS in Chemical Engineering or closely related discipline.
• 7+ years hands-on spray drying experience in pharma/biotech or related fields.
• Experience with facility start-up, commissioning, and equipment qualification.
• Strong knowledge of cGMP requirements and commercial manufacturing operations.
• Lab/pilot-plant experience with solvents and fine powders; PPE required.
• Travel up to 10% for vendor FAT/SAT or tech transfer.

Responsibilities

• System owner of commercial spray drying equipment, including solution preparation, spray drying, and secondary drying systems.
• Oversee creation and revision of equipment documentation packages.
• Lead continuous improvements to reduce cycle times, increase yields, and improve consistency; perform root cause analyses.
• Coordinate spare parts, preventative maintenance, calibration, and commissioning with multiple departments.
• Support clean‑in‑place systems and develop knowledge base of equipment performance.
• Design and execute DOEs/QbD studies to define CPPs/CMAs and robust design spaces.
• Analyze data, write protocols/reports, and present findings to clients and internal stakeholders.
• Collaborate cross‑functionally during batch execution and deviations/CAPAs.
• Champion process safety and GMP alignment in development and clinical manufacturing.

Skills

Spray drying

GMP experience

Data analysis

Cross-functional collaboration

Problem solving

Education

BS in Chemical Engineering

Job description

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.

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, increased yields, and improved 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.

Qualifications

• 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.

Additional Requirements

• 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.
• 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%).

Benefits Summary

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long‑term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon. The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.