Principal, Sterile Product Operations Engineer

Responsibilities

• Drive sterilization LCM initiatives, including site transfers, dual sourcing, dose optimization, and sterilization modality changes to improve supply continuity and operational efficiency.
• Drive implementation and adoption of alternative sterilization technologies, including eBeam, gamma, X-ray, and ethylene oxide, to improve operational flexibility, resilience, and cost efficiency.
• Serve as the global sterilization subject matter expert, establishing technical standards, policies, and best practices across manufacturing sites and product platforms.
• Support the execution and continuous improvement of the corporate sterile products strategy across pharmaceutical, medical device, biologic, and cell & gene therapy portfolios.
• Manage individual technical projects, applying specialized knowledge to achieve objectives and drive innovation.
• Develop, implement, and evaluate new production materials, equipment, and technologies before mass production.
• Complete manufacturing research and development to solve problems related to production cost and quality and conduct technical feasibility tests to ensure production efficiency.
• Evaluate project capacity as the basis for production process design and development and develop and implement standard manufacturing procedures.
• Evaluate production processes to reduce overall costs and determine product quality standards.
• Arrange equipment and tools to support production.
• Select and communicate with vendors to determine product specifications and ensure timely delivery within budget.
• Engage with partner functions such as research and development, commercial, and quality.
• Make operational decisions for projects, directly impacting project performance and innovation.
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs) and maintaining accurate documentation.
• Ensure rigorous quality control, complete all required training, and meet individual job requirements while contributing to the organization's overall compliance.
• Commit to continuous improvement and compliance with regulatory requirements.

Preferred Qualifications

• Demonstrated expertise in terminal sterilization technologies, including Ethylene Oxide (EO), Radiation Sterilization (Gamma, Electron Beam, X-Ray), and Steam (Moist Heat).
• Strong aseptic processing and contamination control background.
• Working knowledge of cell and gene therapy manufacturing operations and regulatory requirements.