Alcon
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 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: 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
Alcon Careers See your impact at alcon.com/careers #LI-DNI ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards Alcon's Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon's Corporate Social Responsibility including our Total Rewards, click here Pay Range $105,600.00 - $158,400.00
Pay Frequency Annual
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
alcon.recruitment@alcon.com
and let us know the nature of your request and your contact information.
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: 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
Alcon Careers See your impact at alcon.com/careers #LI-DNI ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards Alcon's Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon's Corporate Social Responsibility including our Total Rewards, click here Pay Range $105,600.00 - $158,400.00
Pay Frequency Annual
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
alcon.recruitment@alcon.com
and let us know the nature of your request and your contact information.