Senior Process Engineer, Spray Drying

Serán BioScience • Bend, OR

1d • Onsite

About The Position

Serán Bioscience seeks a Senior Process Engineer with expertise in spray drying manufacturing technology to aid in the commercial expansion of novel drug products. This position will serve as the technical owner of commercial spray drying systems, ensuring reliable, efficient, and compliant operation across solution preparation, spray drying, and secondary drying unit operations. This role combines hands‑on process expertise with long‑term system stewardship, driving continuous improvement, equipment reliability, and product quality. The Senior Process Engineer, Spray Drying develops deep knowledge of equipment performance, analyzes trends to anticipate issues, and partners cross-functionally to maintain world-class manufacturing capability. They oversee documentation, maintenance strategies, CIP implementation, and process optimization efforts that support safe, consistent, and scalable production. As the system owner, the 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.

Requirements

• Strong understanding of spray‑drying principles, including atomization, heat/mass transfer, drying kinetics, and particle engineering
• Ability to interpret and optimize process parameters such as inlet/outlet temperatures, feed properties, airflow, and atomization settings
• Experience with commercial spray dryers, solution preparation systems, secondary drying equipment, and associated utilities
• Proficiency in analyzing process data, identifying trends, and applying statistical tools (DOE, SPC, capability analysis)
• Ability to perform mass/energy balances, process modeling, and root‑cause investigations
• Working knowledge of cGMP, equipment qualification (IQ/OQ/PQ), and process validation requirements
• Familiarity with batch documentation, change control, deviation investigations, and CAPA systems
• Ability to support client‑facing technical discussions, tech transfers, and lifecycle management activities
• Understanding of regulatory expectations for equipment cleaning, CIP systems, and contamination control
• Ability to manage equipment documentation packages, including SOPs, maintenance plans, and calibration requirements
• Skilled in collaborating with Maintenance, Calibration, and Supply Chain to manage spare parts, PM schedules, and equipment reliability
• Capability to lead continuous improvement initiatives focused on yield, throughput, reliability, risk analysis, and budgetary goals
• Strong troubleshooting skills for resolving process deviations, equipment failures, and quality issues
• 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
• Ability to collaborate effectively with stakeholders across the organization and client teams
• 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
• Ability to translate technical findings into clear, actionable recommendations for both technical and non‑technical audiences
• Comfortable coordinating across departments to align on schedules, priorities, and operational strategies
• Strong technical writing skills for authoring reports, investigations, protocols, and equipment documentation
• Ability to maintain a long‑term knowledge base of equipment performance and use data to drive decision‑making
• Competence in using digital systems such as MES, LIMS, CMMS, or similar platforms (depending on the facility)
• Detail‑oriented mindset with a commitment to quality and compliance
• Proactive, resourceful, and able to manage multiple priorities in a fast‑paced CDMO environment
• Proficient with Microsoft Office Suite or related software
• BS/MS in chemical Engineering, Mechanical Engineering, or closely related discipline
• 8+ years of experience in pharmaceutical manufacturing, process engineering, or industrial engineering
• Hands-on experience with facility start-up, commissioning, and equipment qualification
• Strong knowledge of cGMP requirements and commercial manufacturing operations
• Prolonged periods of sitting or standing at a desk and working on a computer
• Prolonged periods of sitting, standing, and moving throughout a manufacturing environment
• Must be able to lift fifteen pounds at times
• Adheres to consistent and predictable in-person attendance
• 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.

Responsibilities

• System owner of commercial spray drying equipment, including solution preparation, spray drying, and secondary drying systems
• Assess and implement continuous improvements of spray dryer and associated unit operations
• Collaborate with other departments on strategy and schedules for spare parts, preventative maintenance, and calibration
• 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
• Maintain deep, data‑driven knowledge of equipment performance and analyze trends to identify risks, opportunities, and long‑term improvement strategies
• Oversee creation, revision, and lifecycle management of equipment documentation packages, including SOPs, batch records, and qualification documents
• Lead troubleshooting efforts for process deviations, equipment issues, and product quality concerns using structured problem‑solving tools
• Support scale‑up, tech transfer, and process validation activities for new and existing pharmaceutical products
• Partner with Maintenance, Calibration, and Supply Chain teams to develop strategies and schedules for spare parts, preventative maintenance, and calibration activities
• Collaborate with Quality, Validation, and Manufacturing to ensure equipment and processes meet cGMP, regulatory, and client expectations
• Work with Engineering and Operations to implement and optimize clean‑in-place (CIP) systems for spray‑drying equipment
• Support internal and external audits, including client visits and regulatory inspections
• Contribute to technical reports, investigations, and client communications with clarity and scientific rigor
• Responsibilities may increase in scope to align with company initiatives
• Performs other related duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees