VALIDATION COMPLIANCE ENGINEER

Description

Job Summary: Plan and execute qualification and validation activities for areas, utilities, equipment, and complex processes in the pharmaceutical industry. Key Highlights: 1. Committed to the health and well-being of millions of people. 2. Opportunity to transform the future of healthcare. 3. Technical support for new facility projects and audits. **Date:** May 19, 2026 **Address:** TLAJOMULCO DE ZUÑIGA, JALISCO, MX **Company:** Grupo PiSA Live your purpose and make a difference with Grupo PiSA. With over 80 years of history, Grupo PiSA is a 100% Mexican company committed to the health and well-being of millions of people, both in Mexico and internationally. Our growth reflects the effort, passion, and dedication of a team focused on excellence. Join us and become part of a company where every day is an opportunity to live "A Life in Service of Life". Together, we can transform the future of healthcare and leave a positive impact on the world! **Employment Type** Confianza**Job Objective** Plan and execute qualification and validation activities for areas, utilities, equipment, and high-complexity technical processes that significantly impact product quality, ensuring both initial assessment of new facilities and maintenance of validated status for operations, thereby guaranteeing regulatory compliance and product quality.**Responsibilities and Activities** * Support the validation team in designing documents for qualification and validation activities, based on sound technical, scientific, and regulatory foundations, to demonstrate that the evaluated process element is suitable for its intended use. * Design documents for qualification and validation activities, applying technical and scientific knowledge aligned with applicable regulations, to verify that the evaluated process is appropriate for its intended use. * Execute tests defined in the approved qualification/validation protocol, ensuring data sustainability and traceability. * Analyze data obtained from equipment, systems, and/or processes, and document findings in qualification/validation reports to validate proper usage or functionality. * Track deviations identified during execution of assigned qualifications or validations. * Provide internal and/or user-facing technical support during new facility, equipment, and/or system projects, as well as support during internal and external audits for qualification/validation documentation presentation. Experience * Qualification and validation processes for areas, utilities, equipment, and processes \- 2 years * Qualification of equipment for controlled environmental conditions \- 1 year * Thermal mapping \- 1 year * Pharmaceutical industry \- 2 years. Knowledge * Current Official Standard NOM-059-SSA1 "Good Manufacturing Practices for Medicinal Products" * WHO Supplement No. 8 "Temperature Mapping of Storage Areas" * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Education Bachelor's Degree**Complementary Profile** * Desired experience using thermohygrometers. * Desired knowledge of ERP systems (SAP). * Intermediate English proficiency. At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunity, inclusion, and diversity. Our selection processes are FREE OF CHARGE; please report any irregularities to lineaeticagrupopisa@letica.email