Principal Engineer, Drug Product, Global Engineering Technical Authority

The Principal Engineer, Drug Product will provide visionary leadership and technical expertise across global manufacturing operations, focusing on sterile drug product processes, including filling, packaging, and labeling equipment. This role will be responsible for building and leading a Technical Authority organization, ensuring the global standardization of facilities, process, equipment, and systems. The individual will drive excellence in both capital project execution and continuous improvement initiatives, while also providing critical support to ensure compliance with regulatory standards.

This position plays a key role in defining engineering best practices aligning with global manufacturing strategies and providing technical oversight across facilities worldwide. The ideal candidate will demonstrate expertise in filling, labeling, and packaging equipment in a regulated environment, leading cross-functional teams to achieve business goals.

• Lead the development of a Technical Authority organization to support manufacturing operations and provide expert guidance on engineering decisions for drug product processes globally.
• Act as the Global Subject Matter Expert (SME) in primary and secondary packaging, filling, labeling, closing equipment, and processes.
• Establish and maintain best practices and functional standards that enable global standardization of facilities, engineering processes, equipment, and systems.

• Lead the Front-End Engineering for capital projects, including scope determination, design review, manufacturability assessments, cost analysis, risk evaluation, and schedule planning for Drug Product projects.
• Oversee and participate in the complete project lifecycle, including conceptual design, engineering, procurement, construction, installation, start-up, commissioning, validation, and qualification of equipment.
• Ensure project documentation is accurate, comprehensive, and compliant with regulatory and internal standards, including URS, functional descriptions, and engineering drawings.

• Develop and own specifications for filling, labeling, and packaging equipment, leading the selection and assessment of equipment vendors.
• Collaborate with cross-functional teams to define user requirements, design specifications, and process parameters, providing input into risk assessments (FMEA) and operational strategies.
• Drive the development of Engineering Turnover Packages, ensuring accurate documentation, operating manuals, and GMP compliance for all process equipment.

• Ensure that all global manufacturing processes comply with regulatory requirements (e.g., GMP, FDA, ICH, EMA), including validation and qualification activities.
• Lead Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning of equipment at vendor locations and on-site.
• Support global qualification strategies, including vision systems for Automated Visual Inspection (AVI), and troubleshooting equipment failures while ensuring preventive maintenance and continuous improvement.

• Drive innovation by identifying new technologies for filling and closing equipment, primary and secondary packaging, and vision inspection systems.
• Lead testing and evaluation of new technologies to support the global technical roadmap, providing solutions for emerging business needs and continuous process improvements.
• Act as a technical influencer, providing guidance to senior leadership on business initiatives and strategic capital investments.

• Serve as a problem solver for complex…