QUALITY VALIDATION ENGINEER (COMPUTER SYSTEMS VALDIATION)

At Ecolab we are looking for a Quality Validation Engineer (Computer Systems Valdiation) to join our Computer Software Assurance & Validation Team.
What You Will Do.
Lead or assist in business risk/impact determinations to determine when validation is required.
Develop internal/external connections with development, implementation and business teams to provide CSV expertise and deliverables for new system deployments and rolling out future enhancements.
Develop and manage computer software validation deliverables for large and small computerized systems and automated equipment systems.
Ensure the application of Computerized System Validation best practices, ensuring systems meet industry standards before launch.
Ensure and support the lifecycle approach and risk-based approach to system validation is integrated for systems and business units.
Minimum Qualifications.
Bachelor’s degree in Engineering (preferably Software, Industrial or Systems) Minimum 3 years of experience in quality or engineering roles.
2-5 years of work experience in equipment validation and/or IT field associated with the implementation and validation of computer systems.
Business Fluent in English (B2 - C1).
Excellent written and oral communication skills.
Lead and change management skills.
Knowledge of FDA/EU regulatory requirements and industry best practices for computerized system validation to complete tasks Knowledge of FDA, ISO, GAMP practices, Software development life cycle and risk-based approach to validation Preferred Qualifications.
Experience in medical device or pharma fields.
Experience with GxP (“Good x Practice”) compliance and related Quality & Manufacturing System regulations.
Must have good interpersonal skills and the ability to work closely with cross-functional teams to document validation deliverables throughout the software development lifecycle and during the software maintenance phase.
Experience in preparing, enacting, and driving different teams and ensuring deliverables conforming to various regulations.
Experience in generating, reviewing and executing validation and change control documents, authoring Standard Operating Procedures (SOPs), and providing training on guidance and SOPs.
Experience in driving adherence to QA and IT policies, procedures, industry standards and best practices.
Effective oral and written communication skills, project management experience; organizational skills, attention to detail, and the use of good judgment in a fast-paced environment are essential.
Demonstrated ability to stay current with best practices, existing and emerging technology platforms, architecture industry trends, and systems engineering.
Ecolab’s commitment to diversity, equity and inclusion (DE&I) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves, reach our goals and do what’s right.
Disability certificate will be an asset.
#li-eu Ecolab (NYSE.
CL), socio confiable alrededor de tres millones de clientes en diferentes partes del mundo, es líder mundial en sustentabilidad y ofrece soluciones y servicios de agua, higiene y prevención de infecciones, que protegen a las personas y los recursos vitales.
Con un siglo de historia e innovación, Ecolab cuenta con ventas anuales de $15 mil millones y más de asociados.
Ecolab ofrece soluciones integrales basadas en evidencia científica, información basada en datos y un servicio de primer nivel para avanzar en la seguridad alimentaria, mantener los entornos limpios y seguros y optimizar el uso del agua y la energía.
Además de mejorar la eficiencia operativa y la sustentabilidad para los clientes en los mercados de alimentación, atención médica, ciencias biológicas, alojamiento e industria en más de 170 países en el mundo.
Cuando comience a trabajar en Ecolab, se enfrentará con algunos de los desafíos más significativos del mundo y tendrá la oportunidad de aprender y crecer, dar forma a su carrera, crear impacto y ver rápidamente la importancia de su trabajo.
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colab.
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