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.
Duties and Responsibilities
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 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
Continuous Improvement
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
Project Management
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
Skills, Abilities and Education Requirements
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
Core Competencies
Analytical problem-solving and data-driven decision-making
Ability to work cross-functionally in a fast-paced environment
Strong organizational skills and attention to detail
Continuous improvement mindset
Physical Requirements
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
