Principal Process Validation Engineer

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?

We are seeking a highly skilled Principal Process Validation Engineer with a strong background in Six Sigma methodologies (Green or Black Belt preferred) and supplier process qualification to work at our manufacturing facility in Irvine, CA. This role is critical in ensuring robust, repeatable, and compliant manufacturing processes both internally and at key suppliers. The ideal candidate will lead validation activities, drive continuous improvement, and ensure supplier processes meet regulatory and quality standards.

In this role, a typical day will include:

• Lead and execute process validation activities (IQ/OQ/PQ) for new and existing manufacturing processes.

• Develop and maintain validation master plans, protocols, and reports in compliance with regulatory requirements (e.g., FDA, ISO 13485, IATF

• Apply Six Sigma tools (DMAIC, DOE, SPC, FMEA) to identify and eliminate process variation and improve yield.

• Collaborate with suppliers to qualify new processes, equipment, and materials.

• Conduct supplier audits, process capability studies, and risk assessments.

• Support design transfer and scale-up activities from R&D to manufacturing.

• Partner with cross-functional teams (Quality, Engineering, Supply Chain) to resolve process issues and implement corrective actions.

• Maintain documentation in accordance with GMP and company quality systems.

Experience:

• Bachelor's degree in engineering (Mechanical, Industrial, Optical, Electronic, or related field).

• 5+ years of experience in process validation, manufacturing engineering, or quality engineering.

• Certified Six Sigma Green Belt or Black Belt required.

• Experience with supplier process qualification and auditing.

• Strong knowledge of statistical analysis tools (Minitab, JMP, etc.).

• Familiarity with regulatory standards (FDA, ISO, IATF, etc.).

• Excellent communication, project management, and problem-solving skills.

• Experience in regulated industries (e.g., medical devices, pharmaceuticals, automotive).

• Knowledge of lean manufacturing principles.

• Proficiency in technical writing and documentation.

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

How You Can Thrive at Alcon:

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more

• Travel Requirements: 0-5%

• Relocation assistance: Yes

• Sponsorship available: Yes

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, 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 and let us know the nature of your request and your contact information.