Find & Apply For Chemical / Process Engineer Jobs in Boston, Massachusetts

Responsibilities Lead process development, optimization, and scale-up activities for an innovative microarray patch manufacturing platform from early development through commercial readiness. Establish technical strategies for increasing manufacturing capacity and throughput while maintaining or improving product quality, process capability, and consistency. Apply engineering fundamentals, statistical methods, and data-driven approaches to understand and optimize critical process parameters and their impact on product quality. Develop and utilize first-principles, empirical, and statistical models to characterize manufacturing processes and support scale-up decisions. Design, execute, and interpret statistically based experiments (DoEs) to identify process drivers, establish operating ranges, and resolve complex manufacturing issues. Partner closely with Automation, Technical Operations, Analytical Development, Formulation, Quality, and other cross-functional groups to develop and implement robust manufacturing solutions. Evaluate new equipment, automation technologies, process configurations, analytical methods, and process analytical technologies to support future manufacturing capabilities. Lead technical investigations and troubleshooting efforts involving complex process, equipment, material, and product-performance issues. Develop approaches for analyzing large and complex process datasets and translate findings into actionable process improvements. Establish quantitative relationships between process conditions, critical quality attributes, and overall process performance. Support technology transfer, process validation, manufacturing readiness, and scale-up activities as programs progress toward later-stage development and commercialization. Ensure process development activities are appropriately documented and provide technical content for CMC documentation and regulatory submissions. Operate within a GMP-regulated environment and ensure process development activities are aligned with applicable quality and regulatory requirements. Provide technical leadership to engineers and technicians, including mentoring, coaching, project direction, and development of team capabilities. Depending on level, directly manage a team of process engineers and technical personnel and help establish the organization's long-term engineering capabilities. Work effectively in a fast-paced development environment where priorities, technologies, and manufacturing strategies may evolve rapidly. Drive continuous improvement initiatives and identify opportunities to improve process robustness, efficiency, scalability, and manufacturing reliability. Requirements Bachelor's degree or higher in Mechanical, Chemical, Biomedical, Manufacturing, or a related engineering discipline. 10+ years of relevant experience with demonstrated technical leadership and experience managing engineers or other technical professionals. Demonstrated experience developing, optimizing, and scaling manufacturing processes within pharmaceutical, biotechnology, medical device, drug delivery, or combination-product environments. Strong understanding of engineering fundamentals and demonstrated ability to apply them to complex manufacturing processes. Extensive hands-on experience with Design of Experiments (DoE), statistical analysis, process characterization, and data-driven process optimization. Experience developing quantitative models or other analytical approaches to understand relationships between process parameters and product quality. Experience with one or more of the following is highly desirable: microscale manufacturing, drug delivery systems, precision fluid dispensing, coating, bonding, drying/curing, automated assembly, automated inspection, or other highly automated manufacturing processes.

Pay:

$150,000.00 - $170,000.00 per year

Work Location:

In person