Process Engineer

Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for our new commercial manufacturing operations. This position will ensure that all systems, equipment, and workflows are designed, installed, and commissioned to meet cGMP standards and support efficient, compliant production. Beyond the initial launch phase, this individual will be instrumental in sustaining manufacturing operations by driving long-term operational excellence. This includes leading continuous improvement (CI) projects to ensure that all systems, equipment, and workflows remain efficient, compliant with cGMP standards, and capable of meeting evolving production demands.

• Facility & Process System Start-Up
• 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
• Process Design & Optimization
• 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
• Operational Readiness
• 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