Process Engineering Positions

Job Description 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
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
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
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
• spray drying, blending, granulation, tableting, encapsulation, & tablet coating)

Analytical problem-solving and data-driven decision-making
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
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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.

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