MS&T Validation Engineer I — Drive Process Integrity

alcon; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Alcon is seeking an Associate, Manufacturing Science & Technology (MS&T) to oversee validation activities for aseptic manufacturing facilities. You will provide scientific support for validation, requalification, and revalidation of processes/equipment in compliance with cGMPs and SOPs, while driving continuous quality improvements.

You will conduct OPV, develop risk analyses, monitor process parameters, support tech transfer, and manage change controls.

Qualifications

• 3+ years of validation/qualification experience in pharma or GMP-regulated industry.
• Knowledge of aseptic processes and sterilization.
• Willingness to provide after-hours validation support when required.

Responsibilities

• Conduct OPV, statistical analysis, and data trending for product quality and manufacturing performance.
• Develop Quality Risk Analyses (QRA) for monitoring critical parameters and attributes.
• Identify deviations, risks, and opportunities via data-driven analysis.
• Support process optimization and ensure products stay validated.
• Communicate trends and findings to stakeholders.
• Support tech transfer and batch scale-up with process expertise.
• Coordinate project execution, scope, timelines, and regulatory/validation batches.
• Prepare transfer documentation and manage change controls through approval and closure.
• Prepare/review PQR data and discuss at the appropriate level.
• Execute validation, revalidation, and continuous improvement activities.
• Prepare, review, and approve validation protocols and reports for regulatory compliance.
• Coordinate cross-functional validation activities and stakeholder alignment.
• Drive improvements through data-driven investigation of issues.

Skills

Validation experience

GMP knowledge

Aseptic & sterilization

Data trending & statistics

Education

Engineering or scientific degree

Job description

Alcon is seeking an Associate, Manufacturing Science & Technology (MS&T) to oversee validation activities for aseptic manufacturing facilities. You will provide scientific support for validation, requalification, and revalidation of processes/equipment in compliance with cGMPs and SOPs, while driving continuous quality improvements.

You will conduct OPV, develop risk analyses, monitor process parameters, support tech transfer, and manage change controls.