Software Validation Engineer
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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 **
- 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 *
- 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
- Tiempo completo
Estudios Carrera con título profesional
InglésHablado: Intermedio, Escrito: Avanzado
Disponibilidad p.
viajar** No
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