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Process Engineer, Manufacturing Science & Technology Jobs (On-site work)

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Process Engineer, Manufacturing Science & Technology
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Join our MSAT team in Philadelphia as a Process Engineer for cell therapy commercialization. You will drive process optimization, tech transfer, and characterization to ensure robust, scalable manufacturing. The role requires experience in cGMP biologics, late-stage activities, and BLA-enabling d...
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United States , Philadelphia
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Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
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Until further notice
Explore Process Engineer, Manufacturing Science & Technology jobs and discover a pivotal career at the intersection of innovation and production. Professionals in this field, often known as MSAT Process Engineers, serve as the vital technical bridge between the development of a product and its full-scale, consistent commercial manufacturing. Their core mission is to ensure that manufacturing processes are robust, scalable, compliant, and economically viable. This role is fundamental in high-stakes industries like pharmaceuticals, biotechnology, cell and gene therapy, and advanced manufacturing, where product quality is directly linked to patient safety and business success. A Process Engineer in MSAT typically shoulders a wide array of responsibilities centered on process lifecycle management. A primary function involves leading or supporting technology transfers, moving processes from development labs or one manufacturing site to another, ensuring knowledge is accurately translated and operational readiness is achieved. They are deeply involved in process optimization and characterization, employing Quality by Design (QbD) principles to identify critical process parameters and define proven acceptable ranges. This work directly supports validation activities like Process Performance Qualification (PPQ) and provides the scientific backbone for regulatory submissions. When in production, these engineers provide ongoing technical oversight, analyzing manufacturing data, investigating deviations, and implementing corrective actions to enhance yield, consistency, and efficiency. They are also tasked with troubleshooting complex process issues, applying root-cause analysis to restore or improve process performance. The typical skill set for these jobs is both broad and deep. A strong foundation in engineering principles (chemical, biochemical, or biomedical) is essential, coupled with a thorough understanding of cGMP (current Good Manufacturing Practice) regulations and ICH guidelines. Technical expertise in specific unit operations relevant to the industry—such as cell culture, purification, formulation, or aseptic processing—is required. Successful professionals are analytical problem-solvers, proficient in data analysis and statistical tools. They must be excellent communicators, capable of conveying complex technical information to cross-functional teams including Development, Quality, Regulatory Affairs, and Operations. Project management skills are valuable for coordinating multiple activities and timelines. Typically, employers seek candidates with a Bachelor’s or advanced degree in an engineering or life science discipline, complemented by several years of relevant experience in process development, manufacturing, or a technical support role. Pursuing Process Engineer, Manufacturing Science & Technology jobs means embarking on a career dedicated to operational excellence and continuous improvement. It is a role for those who are passionate about applying scientific rigor to real-world production, ensuring that groundbreaking therapies and products are delivered reliably to the market. If you are an engineer who thrives on solving technical challenges and wants to see your expertise directly impact product quality and availability, this profession offers a dynamic and impactful career path.

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