The Chemical Research and Development group in Groton CT is seeking candidates for an Associate of Manufacturing Technology Engineer (MTE) role in the API Manufacturing group! This role is part of Worldwide R&D in Medicinal Sciences and is responsible for the development of process technology for the production of active pharmaceutical ingredients (API).
The Associate will take primary direction from a senior Manufacturing Technology Engineer. MTEs are involved in the design and deployment of novel equipment systems for the manufacture of clinical API supplies. In this role, MTEs primary responsibilities are to ensure that the "end user" perspective factors prominently in the evolution of innovative equipment designs, and to actively manage the facility integration of prototypes in compliance with local policies, procedures, and regulatory expectations.
The successful MTE is well-versed in design aspects of the manufacturing facilities (equipment, utilities, controls, procedures, workforce), understanding technical capabilities and limitations so as to properly advise the development and construction of equipment systems from conceptualization through realization. The MTE collaborates with engineers, chemists, and analysts to develop new equipment prototypes, then works with the operations team Global Operations to implement the new systems in the regulated manufacturing areas.
Develop and sustain profound familiarization with the technical design of the CRD manufacturing areas, equipment and utilities, the quality systems used in manufacturing, and the composition and workflows of the operations team.
Integrate effectively into the Flexible API Supply Technologies (FAST) initiative, providing manufacturing and design insight into the evolution of new API manufacturing platform technologies, such as Plug Flow Reactors, Gas/Liquid Flow Systems, Liquid/Liquid Extraction Systems, Continuous Isolation and Drying Technologies, etc.
Work with Engineering, Operations and Environmental Health & Safety (EHS) representatives to ensure that a scale and facility-relevant Process Safety protocol is used to identify and mitigate safety risks associated with new equipment systems.
Coordinate the transition (technology transfer) from laboratory demonstration to manufacturing deployment, leveraging partnerships with Maintenance, Procurement, EHS, and Quality Assurance to create effective project management plans for system roll out.
In concert with the operations team, develop commissioning protocols, standard operating procedures, and cleaning approaches specific to the new equipment systems.
Manage timelines in response to portfolio and technology demand prioritization.
Effective communication skills to update stakeholders of project status.
Supervise operations personnel in the commissioning and use of the new equipment systems, which will typically be integrated to work in sequence with existing batch technologies.
In quick order, complete After Action Reviews for each instance of equipment deployment to ensure that learnings and opportunities for improvement are factored in to the future development and implementation of said technology.
Familiarity with current Good Manufacturing Practices (cGMPs) and prior experience in a manufacturing operations and project management are highly desired.
Mechanical aptitude a plus as this is a "hands-on" engineering role.
Ideal candidate will have also through the course of study, research, or prior employment contributed to the development and testing of prototype mechanical systems and have knowledge and experience working with process control methodologies.
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