Serán BioScience
Senior Process Engineer, Spray Drying
TLDR
Hands-on engineer leading end-to-end spray-drying process development, scale-up, and tech transfers with GMP emphasis in a fast-paced CDMO setting.
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
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
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%).
- 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.
- 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
Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
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.
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.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Benefits
Health Insurance
Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
Employee Assistance Program and pet insurance
An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
Paid Time Off
Serán employees accrue over four weeks of paid time off annually.
Serán BioScience specializes in custom formulation, process development, and clinical manufacturing services aimed at pharmaceutical and biotech clients. We offer tailored drug solutions backed by robust analytical capabilities, enabling the development of novel drug products across various therapeutic applications.
- Founded
- Founded 2016
- Employees
- 51-200 employees
- Industry
- Pharmaceuticals
Process Engineer