Senior Process Engineer, Spray Drying

@ Serán BioScience

Senior Process Engineer, Spray Drying

Posted 4 months ago

This job is still taking applications, but it's been up a while.

About the job

Serán is a biotech company specializing in spray drying for drug products. The role involves developing, scaling, and transferring robust processes, ensuring GMP, safety, quality, and collaboration across departments in a fast-paced environment.

Requirements

Expertise in spray drying unit operations
GMP manufacturing experience
Risk analysis principles knowledge
Data analysis ability
Strong communication skills

Qualifications

BS in chemical or mechanical engineering
7+ years spray drying experience
Facility start-up and qualification
Knowledge of cGMP operations

Full 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.

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%).

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

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