Process Engineer

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