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.Duties And ResponsibilitiesSystem owner of commercial spray drying equipment, including solution preparation, spray drying, and secondary drying systemsOversee creation of and revisions of equipment documentation packagesAssess and implement continuous improvements of spray dryer and associated unit operations driving reduced cycle times, increase yields, improve consistency; lead root cause analyses and FMEAsCollaborate with other departments on strategy and schedules for spare parts, preventative maintenance, calibration, and commissioning/qualificationCollaborate with other departments on implementation and use of clean-in-place systemsDevelop and maintain knowledge base of commercial equipment performance, and analyze trends over timeDesign and execute DOEs/QbD studies to define CPPs/CMAs and establish robust, scalable design spacesData analysis & documentation: write protocols/reports; maintain complete technical records; present findings to clients and internal stakeholdersCross-functional collaboration with Formulation, Analytical, QA/RA, Manufacturing, and Facilities; provide SME support during batch execution and deviations/CAPAsSafety & compliance: champion process safety (PHA, solvent handling, inerting), and ensure GMP alignment in development and clinical manufacturingRequired Skills And AbilitiesExpertise with common unit operations for spray drying, including solution preparation and secondary dryingDemonstrated experience working in and supporting GMP manufacturing linesDemonstrated experience with principles of risk-based decision making and common tools for risk analysisAbility to apply rigorous scientific and engineering principles to guide practical decisionsWorking knowledge of process thermodynamics, fluid mechanics, and heat and mass transferAbility to analyze complex data setsExcellent verbal and written communication skillsAbility to collaborate effectively with stakeholders across the organizationExcellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlinesAbility to function in a fast-paced team environmentEducation And ExperienceBS in chemical Engineering, Mechanical Engineering, or closely related discipline7+ years (or more for Senior/Principal) hands-on spray drying experience in pharma/biotech or specialty chemicalsHands-on experience with facility start-up, commissioning, and equipment qualificationStrong knowledge of cGMP requirements and commercial manufacturing operationsPhysical RequirementsWork in lab/pilot-plant setting with solvents and fine powders; PPE requiredAbility to lift up to :25-40 lbs occasionally; extended periods of standing during operationsSome travel may be required for vendor FAT/SAT or client tech transfer (≤10%)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 97701We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.