Validation Engineer

at  Alcon

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a Validation Engineer, you will be responsible for ensuring that all aseptic manufacturing processes and equipment are validated in accordance with regulatory requirements, industry standards, and company policies at Tuas. In this role, a typical day will include:
Essential Functions

Validation Planning and Execution:

• Initiate change control in Change Control System and ensure approval and closure.
• Support the execution of process validations, revalidations, and short-term improvement projects, liaising with all the relevant parties cross functionally to ensure accurate execution.
• Prepare, review, and ensure validation protocols and report are technically correct and executed as intended.
• Carry out and perform validation test functions safely on an optimum number of studies on a timely basis per risk-based priorities and/or coordinate the timely completion of validation-related testing with Production personnel and internal /external resources involved in activities/projects.
• Participate in the coordination of efforts of multi-disciplined project team on the design, writing, performance, documentation, and approvals of validation studies.
• Ensure high scientific quality of all studies carried out in a safe manner.
• Evaluate proposed changes to SOPs and MBRs for compliance with validated parameters and jurisdictional requirements.
• Support continuous process and quality improvements.
• Support the investigational activities involving product- / process-related issues.
• Supports other Validation Engineers to assess need and plan validations / re-validations / verifications, consulting, approving, and reviewing the process validation master plan, together with the Validation Engineers.

Documentation and Reporting:

• Prepare and gain approval of validation documentation on a timely basis.
• Ensure protocols are executed as intended.
• Prepare comprehensive validation reports summarizing results and compliance with acceptance criteria.
• Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
• Maintain accurate and detailed records of all validation activities.
• Ensure validation documentation meets regulatory requirements (FDA, EMA, etc.) and industry standards (ISO, GMP).
• Approves both Validation Protocols and Reports
• Participate and / or lead (case-by-case) Change Controls to its products and related processes.
• Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations.
• Annual Product Review/Product Quality Review (APR/PQR):
• Prepare and review the PQR data and provide the correct level of discussion on it.

Continuous Improvement:

• Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
• Actively participate and represent their product(s) in the relevant committees, where the improvements on weak point products are planned, prioritized and monitored.
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
• Initiate and/or support critical root cause investigation (e.g. observation of Out Of Spec (OOS) and other deviations) involving cross-functional teams.

Problem Solving and Troubleshooting:

• Investigate and resolve validation-related issues and deviations.
• Implement corrective and preventive actions (CAPA) to address process or equipment deficiencies.
• Support root cause analysis for any validation failures or process deviations

Audit support and Regulatory Compliance:

• Ensure all validation activities comply with relevant regulatory requirements and industry standards.
• Maintain the work in inspection-readiness level and to provide the necessary support in any internal or external audit.
• Ensures internal audits and Health Authorities (HAs) inspection readiness on matters pertaining to areas of responsibilities and GMP in general.
• Address and resolve any validation-related audit findings or deficiencies as well as manage ad-hoc & planned projects / activities as and when assigned and directed

What You Will Bring to Alcon:

• Diploma/Degree in Engineering or related studies
• GMP knowledge preferred

How You Can Thrive At Alcon:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

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