Descripción y detalle de las actividades
- Execute and lead computerized systems validation activities under GAMP 5
- Develop and review validation documentation: URS, FS, DS, IQ, OQ, PQ
- Ensure regulatory compliance with 21 CFR Part 11 / 820
- Coordinate functional, integration, and system validation testing (MES, eDHR, ERP)
- Manage deviations, CAPAs, and change control related to validated systems
- Collaborate with IT, Quality, and Manufacturing teams to implement digital solutions
- Participate in internal and external audits (FDA, ISO)
- Perform risk assessments and define risk-based validation strategies
- Support system release and maintain validated state
Experiência y requisitos
- +3 years of experience in Computerized Systems Validation (CSV)
- Experience in the medical device industry or other highly regulated environments




- Knowledge of FDA regulations and ISO 13485
- Professional English proficiency
- Experience with digital tools such as MES, eDHR, or ERP systems (preferred)
Beneficios
- Beneficios de acuerdo a la LFT
- Seguro de vida
- Transporte
- Uniforme
- Utilidades garantizadas
- Caja de ahorro
- Servicios medicos en planta
- Comedor
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
**Estudios** Carrera con título profesional
**Inglés**Hablado: Intermedio, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Software Validation Engineer (Csv) (Tijuana)
🏢 Foxconn Baja California, S. A. De C. V.
📍 Tijuana