Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our adaptable, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.

What You Will Achieve

- Support the planning and execution of analytical method validation activities for chemical and physicochemical methods in accordance with approved protocols.
- Prepare and organize samples, standards, reagents, solutions, reference materials, and documentation required for validation studies.
- Execute validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, detection limit, quantitation limit, and method equivalency, as applicable.
- Ensure training records reflect current qualification to perform validation, verification, and routine analytical method activities.
- Verify instrument readiness, calibration status, analytical conditions, and system suitability requirements before executing validation or verification testing.
- Evaluate validation data for compliance with predefined acceptance criteria, including statistical assessment, trend evaluation, and investigation of atypical or out-of-specification results.
- Ensure validation documentation, raw data, calculations, protocols, reports, and quality records comply with Good Manufacturing Practices, Good Laboratory Practices, data integrity expectations, and applicable procedures.




- Document and report validation results in computerized systems, perform data entry and review, support approval workflows, and maintain inspection-ready records.
- Support investigations, deviations, change controls, method transfers, and continuous improvement initiatives related to analytical method lifecycle management.

Here Is What You Need (Minimum Requirements)

- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline with relevant experience in a GMP-regulated laboratory with 4 years of relevant experience.
- 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.
- Ability to organize validation and verification activities, manage multiple priorities, follow approved timelines, and maintain complete, accurate, and inspection-ready records.
- Strong written and verbal communication skills to document technical results, summarize conclusions, support investigations,



and communicate method-related issues to cross-functional stakeholders.
- Proficiency with analytical laboratory instruments and computerized systems used for method validation and verification, including appropriate instrument checks, system suitability evaluation, data entry, review, and interpretation.
- Intermediate English level, for reading and drafting technical documents

Bonus Points If You Have (Preferred Requirements)

- Hands-on experience 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.
- Familiarity with applicable regulatory and compendial expectations, including ICH, USP, EP, JP, or local health authority guidance related to analytical method validation and verification.
- Experience drafting, reviewing, or approving validation and verification protocols, reports, analytical procedures, technical assessments, deviations, investigations, and change controls.
- Experience using laboratory computerized systems such as chromatography data systems, gLIMS, electronic notebooks, document management systems, or quality management systems.
- Proven ability to collaborate with Quality, Regulatory, Manufacturing, Technical Services, and cross-functional laboratory teams to resolve method-related issu

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📌 Químico Analista de Soporte Analítico (Posicion Temporal - 12 meses) (México)
🏢 Pfizer
📍 México