Analytical Method Validation Specialist

As an Analytical Method Validation Specialist at Pfizer in Toluca, Mexico, you will play a crucial role in ensuring the quality and compliance of our products.

What You Will Achieve In this role, you will support the planning and execution of analytical method validation activities for chemical and physicochemical methods. Your responsibilities will include:

• Preparing and organizing samples, standards, reagents, solutions, reference materials, and documentation required for validation studies
• Executing validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, detection limit, quantitation limit, and method equivalency
• Evaluating validation data for compliance with predefined acceptance criteria, including statistical assessment and trend evaluation
• Ensuring validation documentation, raw data, calculations, protocols, reports, and quality records comply with Good Manufacturing Practices, Good Laboratory Practices, data integrity expectations, and applicable procedures
• Documenting and reporting validation results in computerized systems and performing data entry and review

Here Is What You Need (Minimum Requirements) To be successful in this role, you will need:

• A Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline with 4 years of relevant experience in a GMP-regulated laboratory
• Demonstrated experience supporting or executing analytical method validation, verification, transfer, or lifecycle activities for chemical or physicochemical methods
• Ability to interpret analytical methods, validation and verification protocols, compendial procedures, Standard Operating Procedures, technical procedures, and applicable regulatory expectations
• Working knowledge of Good Manufacturing Practices, Good Laboratory Practices, data integrity principles, laboratory documentation requirements, and quality systems applicable to analytical testing
• Strong written and verbal communication skills to document technical results and communicate method-related issues to cross-functional stakeholders
• Intermediate English level, for reading and drafting technical documents

Bonus Points If You Have (Preferred Requirements) If you have hands-on experience in the following areas, it would be an advantage:

• Executing or supporting analytical method validation, verification, transfer, and lifecycle management for pharmaceutical products, raw materials, or components
• Experience with analytical validation techniques such as HPLC, GC, UV-Vis, dissolution, Karl Fischer/water determination, residual solvents, impurity testing, assay, identification, viscosity, and particle size analysis
• Strong understanding of validation parameters, statistical tools, acceptance criteria, data trending, system suitability, and risk-based evaluation of analytical method performance

Other Job Details

• Last day to apply: November 12th, 2026
• Work Location Assignment: On Premise