Principal Engineer - Equipment Integration and Technical Services

## Overview We are seeking a highly experienced **Principal Engineer - Equipment Integration and Technical Services** to serve as the site technical authority for process equipment design, equipment-to-facility integration, and lifecycle technical support at the Middletown drug product facility. This senior individual contributor will provide technical continuity from final design and construction through commissioning, start-up, and routine operations. The role will lead complex design decisions, major equipment and facility modifications, multidisciplinary troubleshooting, and technical risk resolution for Oral Solid Dosage (OSD) manufacturing and packaging systems. The Principal Engineer will lead technical workstreams and mentor engineers without direct people-management responsibility. ## Responsibilities #### **Equipment Design and Integration** - Serve as the site technical design authority for OSD manufacturing and packaging equipment, ensuring that process equipment, facility design, utilities, controls, containment, material flow, and operator access function together as an operable, safe, and maintainable system. - Review and approve equipment layouts, general-arrangement drawings, 3D models, stack-up studies, P&IDs, utility requirements, connection-point data, operating envelopes, structural loads, access platforms, lifting concepts, maintenance clearances, and cleaning provisions. - Translate user, process, and operational requirements into clear engineering criteria, technical specifications, and design decisions; identify gaps between vendor equipment designs and facility capabilities before installation or start-up. - Lead multidisciplinary design reviews and resolve interface gaps among the architectural and engineering firm, construction management team, equipment vendors, installation contractors, automation, CQV, Quality, EHS, Operations, and Maintenance. - Evaluate proposed equipment and facility modifications for cGMP impact, safety, containment, cleanability, maintainability, constructability, capacity, cost, schedule, and future operational flexibility. - Own or lead resolution of critical field RFIs, design clarifications, installation conflicts, and technical deviations, and ensure approved solutions are reflected in final drawings and as-built documentation. #### **Project, Start-up, and Qualification Support** - Provide senior technical oversight during vendor design, FAT, SAT, equipment installation, commissioning, qualification, and handover, with emphasis on integrated system functionality and resolution of issues affecting safety, compliance, capacity, or schedule. - Conduct engineering risk assessments, option analyses, and cost/schedule trade-off evaluations, and present clear, technically supported recommendations to site and project leadership. - Confirm that vendor and contractor technical deliverables are complete, coordinated, and suitable for installation, operation, maintenance, qualification, and future change control. - Establish and maintain site engineering standards, equipment-integration checklists, design-review practices, and technical documentation expectations to improve consistency and reduce rework. - Provide technical leadership and mentoring to equipment engineers and project team members, review complex engineering work, and support development of internal site engineering capability. #### **Lifecycle Technical Services** - Remain the site technical authority for assigned process equipment and integrated manufacturing systems after handover to Operations. - Lead complex troubleshooting, root-cause investigations, deviation support, corrective and preventive actions, and recurring equipment-performance investigations involving multiple disciplines or vendors. - Develop engineering solutions for major modifications, equipment replacement, capacity expansion, new product introductions, technology transfers, and future facility upgrades. - Assess facility and equipment impac…