Principal Process Validation Engineer at Alcon

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in engineering (Mechanical, Industrial, Optical, Electronic, or related field) or equivalent years of directly related experience (high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
5+ years of experience in process validation, manufacturing engineering, or quality engineering
Certified Six Sigma Green Belt or Black Belt
Experience with supplier process qualification and auditing
Strong knowledge of statistical analysis tools (Minitab, JMP, etc.)
Familiarity with regulatory standards (FDA, ISO 13485, IATF 16949, 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
Ability to fluently read, write, understand, and communicate in English

Responsibilities

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

Skills

Process Validation

IQ/OQ/PQ

Six Sigma

DMAIC

DOE

SPC

FMEA

Supplier Qualification

FDA

ISO 13485

IATF 16949

GMP

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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