Principal, Sterile Product Operations Engineer

The Principal, Sterile Product Operations Engineer will lead technical projects at Alcon’s Fort Worth, TX facility, focusing on the development, implementation, and evaluation of new materials, equipment, and technologies for sterile products. The role combines sterilization leadership with manufacturing science and technology execution, while supporting a broader corporate sterile products strategy under GxP requirements.

Key Responsibilities

• Drive sterilization LCM initiatives, including site transfers, dual sourcing, dose optimization, and sterilization modality changes to improve supply continuity and operational efficiency.
• Implement and support adoption of alternative sterilization technologies, including eBeam, gamma, X-ray, and ethylene oxide, to improve operational flexibility, resilience, and cost efficiency.
• Act as the global sterilization subject matter expert, establishing technical standards, policies, and best practices across manufacturing sites and product platforms.
• Support execution and continuous improvement of the corporate sterile products strategy across pharmaceutical, medical device, biologic, and cell & gene therapy portfolios.
• Manage individual technical projects by applying specialized knowledge to meet objectives and drive innovation.
• Develop, implement, and evaluate new production materials, equipment, and technologies before mass production.
• Perform manufacturing research and development to resolve production cost and quality issues, including technical feasibility testing to support efficient production.
• Evaluate project capacity as input to production process design and development, and develop and implement standard manufacturing procedures.
• Evaluate production processes to reduce overall costs and define product quality standards.
• Arrange equipment and tools to support production.
• Select and communicate with vendors to confirm product specifications and support timely delivery within budget.
• Partner with functions including research and development, commercial, and quality to advance project outcomes.
• Make operational decisions for projects that directly impact project performance and innovation.
• Maintain compliance with GxP requirements by following Standard Operating Procedures (SOPs) and maintaining accurate documentation.
• Ensure quality control rigor, complete required training, and meet individual job requirements while contributing to organizational compliance.
• Contribute to continuous improvement and adherence to regulatory requirements; maintain ownership of individual job requirements and support overall compliance.

Required Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• Fluent ability to read, write, understand, and communicate in English
• 5 years of relevant experience
• Onsite location

Relevant Technologies

• eBeam
• gamma
• X-ray
• ethylene oxide
• Terminal sterilization technologies
• Ethylene Oxide (EO)
• Electron Beam (E-Beam)
• Steam (Moist Heat)

Location and Travel

• Location: Fort Worth, TX (onsite)
• Travel requirements: 25–50% domestically and internationally

Benefits

• Robust benefits package including health, life, retirement, flexible time off for salaried associates, and paid time off for hourly associates, plus more.
• Relocation Assistance: Yes

Sponsorship

• Sponsorship available: No

Preferred Skills and Experience

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