Alejandra Mondragón

Biomedical engineer with a specialty in quality systems, with 5 years of experience in the pharmaceutical industry and interest in communication systems and networks.

From 2021 to present at Fresenius Medical Care

Process Validation Engineer

• Completes projects as assigned by the department manager. Able to prioritize responsibilities and execute the projects with clear objectives.
• Generates (redaction) and review validation protocols, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports (full understanding of Product Development life cycle).
• Proficiently develops and performs testing and evaluation of Process validations and Software validations in compliance with Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ, PPQ).
• Evaluates and execute validation/requalification.
• Maintain and assist in stablishing standardized methods and procedures for software, process, HVAC systems and test methods validations and ensure standardized methods are implemented.
• Maintain compliance with applicable GMP Standards, ISO Standards, Local Standard Operating Procedures (SOP’s) and company policies.
• Work on problems with moderate scope where analysis of situation or data requires a review of factors, risk assessment tools (e.g. FMEA) to evaluate the risks and required mitigation plans associated with the applicable equipment, method or product.

Production Supervisor

• Supervision of the production process for the manufacture of the Liquid Acid Concentrates product.
• Oversight of the documental compliance and personnel management to ensure the process quality standards and regulations.
• Achievement of daily production targets to meet annual goal.
• Compliance whit GMP, GDP.

2015-2018 Universidad Autonoma de Guadalajara

Bachelors degree in Biomedical Electronic Engineer

2019 Universidad Autonoma de Guadalajara

Quality Systems Speciality