Job Summary: We are seeking a mid-level CSV Specialist to build a career in computerized systems validation, participating in regulated projects and regulatory compliance initiatives within Life Sciences. Key Highlights: 1. Participation in real-world Computerized Systems Validation (CSV) projects 2. Professional development in digital GxP compliance 3. Exposure to regulatory compliance projects in Life Sciences Opportunity to advance your career in **Computerized Systems Validation (CSV)** We seek a mid-level CSV Specialist eager to gain hands-on experience in regulated projects. This position is ideal for professionals who already possess foundational knowledge of CSV and wish to grow professionally. What you will develop in this role: * **Participation in real-world computerized systems validation projects (LIMS, ERP, QMS, SCADA)** * Experience in documentation (English/Spanish) and execution of CSV activities under GxP guidelines * **Exposure to regulatory compliance projects in Life Sciences** * Close collaboration with specialized consultants and client teams We are looking for individuals with: * **Experience in regulated environments or computerized systems validation.** * Interest in building a career in Computerized Systems Validation * **Ability to work autonomously and learn quickly** * English is mandatory and non-negotiable — minimum B2 level with fluent conversational ability, as communication with clients in Europe and the USA will be required. Responsibilities: * **Preparation of CSV documentation in English and Spanish** * Development of validation plans, protocols, scripts, reports, SOPs, traceability matrices, and all documents related to system lifecycle management. * **Execution of computerized systems validation testing** * Participation in projects under the guidance of senior consultants or project managers * **Direct interaction with clients on regulatory compliance projects** * Identification of risks and improvement opportunities for systems and technologies * Experience validating systems such as LIMS, ERP, EDMS, EQMS, SCADA, cloud-based or on\-premise systems, spreadsheets Required Knowledge: * GAMP 5, 21 CFR Part 11, Data Integrity, Good Documentation Practices, International Regulations (FDA / PIC/S / EudraLex / WHO) Profile * **Bachelor’s degree in Chemistry, Pharmacy, or Engineering (IT degrees with experience in pharmaceutical and medical device industries are desirable)** * 3–6 years of experience in the Life Sciences industry * **English proficiency is mandatory** * Experience executing CSV activities and preparing validation documentation in English and Spanish. * **This role does not include personnel management responsibilities.** **Desirable Experience in:** * Data Integrity assessments **Risk Management (FMEA / ISO 31000\)** **Offer:** * Participation in international projects * **Professional development in digital GxP compliance** * Collaboration with specialists in pharmaceutical validation and regulation **Salary: MXN 18k \- 20k per month, depending on experience and English proficiency** * Statutory benefits * Hybrid work model (based in CDMX) If you are interested in advancing your career in CSV and digital compliance, please send us your **CV in English**. Salary: $18,000\.00 \- $19,222\.19 per month Benefits: * Flexible working hours Work Location: Hybrid remote in 03920, Insurgentes Mixcoac, CDMX