Process Engineer Manager Jobs in Oregon (NOW HIRING)

• 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

• 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
• Excellent communication and documentation skills

• 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

• 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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.