Principal, Sterile Product Operations Engineer

U339 Alcon Vision, LLC. Company; Fort Worth (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

Alcon in Fort Worth, TX, is seeking a Principal, Sterile Product Operations Engineer to lead technical projects for new materials, equipment, and technologies in manufacturing science & technology. You will apply project management and technical problem-solving to improve sterilization processes and drive efficiency.

The role requires experience with EO, gamma, e-beam, X-ray sterilization and a strong quality/regulatory mindset within a global operation. Onsite with travel).

Qualifications

• Bachelor’s degree or equivalent with directly related experience.
• Minimum of 5 years in sterile processing or related manufacturing.
• Ability to manage projects and coordinate across functions.

Responsibilities

• Lead sterilization technology initiatives including EO, gamma, e-beam, X-ray and steam.
• Drive site transfers, dual sourcing, dose optimization and modality changes.
• Develop standards and best practices across manufacturing sites.
• Support corporate sterile products strategy across portfolios.
• Evaluate production processes and implement improvement projects.
• Ensure compliance with GMP/GxP and maintain documentation.

Skills

5+ years experience

Project management

Problem solving

Collaborative work style

Education

Bachelor’s Degree or Equivalent

Tools

Ethylene Oxide sterilization

Radiation sterilization

Gamma sterilization

Electron Beam (E-Beam)

X-Ray sterilization

Steam sterilization

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes. The Principal, Sterile Product Operations Engineer (Manufacturing Science & Technology Engineering) , is primarily responsible for leading technical projects to develop, implement, and evaluate new production materials, equipment, and technologies. You will be expected to apply project management skills, technical expertise, and problem-solving abilities at our Facility in Fort Worth, TX.

Specifics Include: 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. Associates are responsible for meeting their individual job requirements and contributing to the organization's overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations. Location: Onsite Travel Requirements: 25 – 50% domestically and internationally Relocation Assistance: Yes Sponsorship Available: No

WHAT YOU’LL BRING TO ALCON:

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) The ability to fluently read, write, understand and communicate in English 5 Years of relevant experience

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

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

HOW YOU CAN THRIVE AT ALCON:

Collaborate with teammates to share standard processes and learnings as work evolves! Join Alcon’s mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives. Grow your career in a highly collaborative and diverse environment. Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.