Serán BioScience · 18 hours ago
Process Engineer
Bend, Oregon
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSerán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for their new commercial manufacturing operations. The role involves ensuring systems meet cGMP standards and driving long-term operational excellence through continuous improvement initiatives.
Biotechnology
No H1B
Responsibilities
Lead design and engineering activities associated with process equipment for new installations and/or continuous improvements
Lead engineering activities for facility process systems through design, installation, and commissioning, including CIP, purified water, solvent distribution, and compressed gases
Oversee process equipment installation, commissioning, and qualification (URS, FAT, SAT, IQ/OQ/PQ)
Coordinate with vendors and contractors to ensure timely and compliant start-up of manufacturing systems
Develop and execute commissioning plans, risk assessments, and readiness checklists
Design and refine commercial-scale manufacturing processes for oral solid dosage forms and enabling technologies
Perform capacity analysis, cycle time studies, and throughput modeling to ensure production efficiency
Implement Lean and Six Sigma methodologies to reduce waste and improve process reliability
Conduct formal risk assessments for existing process system to proactively mitigate quality and safety risks
Drive readiness activities for commercial launch, including supporting process validation and GMP documentation
Partner with Validation, QA, and Manufacturing to ensure compliance with regulatory requirements
Support tech transfer from development to commercial scale
Collaborate with the Facilities and Maintenance teams to establish preventive and predictive maintenance schedules for process systems
Draft and review standard operating procedures (SOPs) for the operation, cleaning, and troubleshooting of new process systems
Analyze production data to identify bottlenecks and implement corrective actions
Drive cost reduction initiatives and efficiency improvements without compromising quality
Participate in deviation investigations and CAPA implementation
Serve as the primary technical process system owner to ensure stable and robust manufacturing
Contribute to project timelines, resource planning, and budget adherence
Facilitate cross-functional project meetings and provide regular status updates to senior leadership
Provide engineering input during client audits and regulatory inspections
Proactively identify project risks and implement mitigation strategies
Qualification
Required
BS/MS in Industrial Engineering, Chemical Engineering, Mechanical Engineering, or 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
Proficiency in process modeling, workflow analysis, and Lean/Six Sigma tools
Excellent communication and documentation skills
Preferred
Experience with oral solid dosage forms and enabling technologies (e.g., spray drying, blending, granulation, tableting, encapsulation, & tablet coating)
Familiarity with facility design for regulated environments
Knowledge of ERP/MES systems and digital manufacturing tools
Project engineering experience in a regulated industry
Benefits
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
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase