Seranbio10d ago

Process Engineer

United States·BendFull-time Exemptmid

EngineeringProcess Engineer

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Quick Summary

Overview

Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems,

Technical Tools

EngineeringProcess 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 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

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

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