Principal Validation Engineer

Alcon Laboratories India Pvt Ltd; Bengaluru; On-site; INR 300,000 - 520,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Alcon Laboratories India Pvt Ltd in Bengaluru seeks a Senior Principal, Validation to lead validation projects, apply advanced analytics, and ensure regulatory compliance across cGMPs and SOPs. You will design manufacturing processes, troubleshoot issues, and guide teams through validation activities in a fast-paced, globally regulated environment.

You will mentor teams, drive robust validation strategies, and deliver high-quality documentation and CAPA-driven improvements.

Qualifications

• Bachelor's or master's degree with 7+ years of experience.
• Conduct data analysis and apply statistical tools to support process monitoring.
• Prepare, review, and maintain validation protocols, reports, and technical documentation.
• Conduct risk assessments and drive data-based problem solving to identify root causes and implement effective CAPA solutions.

Responsibilities

• Lead validation projects and develop validation strategies.
• Build effective relationships with teams to address technical problems.
• Design manufacturing processes, conduct tests, and ensure quality standards.
• Impact project performance by managing resources and decisions.
• Support validation activities ensuring cGMPs and SOPs compliance.
• Drive continuous improvement in quality and efficiency.
• Adhere to GxP regulations and maintain complete documentation.
• Complete required training and meet job requirements.

Skills

Data analysis

DOE/SPC Cp/Cpk

Validation project Mgmt

CAPA

Education

Bachelor's or Master's degree

Job description

Principal, Validation (T) Summary of Position: 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 Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Principal, Validation (Science/Tech/Engineering Path), is primarily responsible for conducting technical analysis of product implementations and ensuring compliance with company and regulatory standards. You will lead validation activities, troubleshoot technical issues, and design manufacturing processes.

Key Responsibilities

• Manage validation projects, applying specialized knowledge to achieve objectives and develop and implement validation strategies
• Build effective and meaningful relationships with teams to address technical problems and suggest solutions, acting as a local representative to customers
• Design manufacturing processes, conduct tests, troubleshoot issues, and ensure quality standards
• Impact project performance by making operational decisions and managing resources
• Support process, system, and equipment validation activities, ensuring compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs)
• Drive continuous improvement in quality and efficiency
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintaining accurate and complete documentation
• Complete all required training and meet individual job requirements, contributing to the overall compliance of the organization

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.

Key Requirements/Minimum Qualifications

• Bachelor's or master's degree with 7+ years of experience.
• Conduct data analysis and apply statistical knowledge & tools (DOE, SPC, Cp/Cpk) to support process monitoring & improvements.
• Assist in technical feasibility studies and process optimization initiatives.
• Prepare, review, and maintain validation protocols, reports, and technical documentation.
• Conduct risk assessments and drive data-based problem solving to identify root causes and implement effective CAPA solutions.

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not 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 status, disability, or any other reason.

Experience Level Senior Level