Principal Process Validation Engineer

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 16949).

• 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:

• Bachelors 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 Youll Bring to Alcon:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)

• The ability to fluently read write understand and communicate in English

• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcons 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.