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QA Engineer

CSV Engineer

SKAN

Allschwil

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Role description

Founded in 1968,
SKAN
is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organization have made SKAN a market leader and a key partner to industry and research laboratories.

At a glance

To ensure and continuously improve the quality of our automation software, we are looking for an experienced Computer System Validation Engineer (CSV) to join our Automation Software QC Team in Allschwil. In this role, you will design and optimize our testing procedures for automation software. You will work closely with the Automation, Quality Assurance, and Product Management departments and contribute to ensuring that our software solutions comply with applicable quality and compliance requirements. This position offers a high degree of autonomy as well as the opportunity to actively develop processes and take ownership of responsibilities.

Please note that this role is not focused on software programming. The main focus is on quality assurance, risk assessment, and compliance with regulatory requirements.

Responsibilities

Further develop and design testing procedures in compliance with regulatory requirements (in particular GAMP 5 and 21 CFR Part 11)
Contribute to the development and continuous improvement of internal processes in collaboration with related departments
Coordinate quality-related activities between the Automation departments, Quality Assurance, and Product Management
Create and maintain specifications and requirements for automation software
Plan, perform, and document software tests and conduct reviews
Perform risk analyses as part of the software testing process
Manage and maintain validation documentation (e.g., test plans, test protocols, and test reports)
Create and maintain training materials, work instructions, and guidelines
Conduct training sessions for internal stakeholders
Support audits and inspections within your area of responsibility

Hardskills

Degree in Engineering, Natural Sciences, Computer Science, or a comparable field
Several years of professional experience in a GMP-regulated environment, ideally in Computer System Validation (CSV), automation, or quality assurance
Well-founded knowledge of relevant regulatory requirements, particularly GAMP 5 and 21 CFR Part 11
Experience in the creation, execution, and documentation of software validation activities
Basic understanding of software architectures, programming logic, and automated systems
Confident use of common computer applications and electronic documentation systems
Excellent written and spoken English skills; German language skills are an advantage

Softskills

Strong communication skills and confidence when interacting with internal stakeholders
High level of personal responsibility and an independent, structured way of working
Analytical mindset and solution-oriented approach
Ability to explain complex topics in a clear and understandable manner
Strong organizational and coordination skills
Strong quality awareness combined with a high degree of accuracy and reliability

We offer you

An open and collaborative corporate culture
Freedom to contribute and develop ideas
Opportunities to participate in sports and social activities
Professional development and continuous learning opportunities, especially at our SKAN Academy
Comprehensive and career-focused onboarding
Quick decision-making paths and flat hierarchies
Transparent and open communication
5 weeks of vacation, with the option to take additional leave

Additional information

We look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.

For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed.

For questions please contact Angelika Läuchli.

This is a saved copy of a posting published elsewhere. Postings get taken down without notice — check the employer's site before applying. mentors.coach is not the hiring party.

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Role description

Descripción:

Apoyar al área de Procesos de Negocio en el análisis, diseño, documentación y mejora de procesos operativos, asegurando que las iniciativas del área se ejecuten de forma ordenada, clara y alineada a las necesidades del negocio.

El rol tiene un fuerte componente operativo, pero también requiere criterio para proponer mejoras, priorizar iniciativas y servir como punto de conexión entre negocio, operaciones y tecnología.

Responsabilidades principales:

1. Análisis y documentación de procesos

Levantar información con diferentes áreas internas (Operaciones, Tecnología, Cumplimiento, Legal, Comercial, Finanzas).
Documentar procesos actuales y futuros (As-Is / To-Be).
Elaborar diagramas, flujos y documentación de procesos y reglas de negocio.
Identificar cuellos de botella, riesgos operativos y oportunidades de mejora.

2. Diseño y creación de workflows

Diseñar y mantener workflows operativos para la gestión o automatización de procesos.
Crear y actualizar workflows en archivos JSON, incluyendo validaciones y reglas básicas.
Trabajar en conjunto con áreas técnicas para la implementación de estos flujos en sistemas internos.
Ejecutar pruebas funcionales y asegurar el correcto funcionamiento de los workflows.
Documentar la lógica y reglas de cada flujo.

3. Gestión y seguimiento de iniciativas

Dar seguimiento a planes de trabajo, tareas y pendientes del área.
Coordinar reuniones, preparar minutas y dar seguimiento a acuerdos.
Identificar dependencias con otras áreas y alertar riesgos o bloqueos.
Apoyar en la priorización de iniciativas de acuerdo con impacto y esfuerzo.

4. Gestión de procesos y mejora continua

Tratar los procesos y workflows como activos vivos del negocio, sujetos a mejora constante.
Proponer ajustes o mejoras con base en la operación diaria y necesidades del negocio.
Traducir requerimientos del negocio en definiciones claras para su implementación.
Dar seguimiento a cambios y asegurar que los procesos cumplan con el objetivo para el que fueron diseñados.

5. Análisis operativo y preparación de entregables

Analizar información relacionada con procesos, indicadores operativos y desempeño de flujos.
Preparar reportes, presentaciones y resúmenes ejecutivos para la gerencia.
Mantener control documental de las iniciativas del área.

6. Soporte operativo y colaboración transversal

Administrar repositorios, controles y documentación del área.
Colaborar con distintas áreas en temas relacionados con procesos y operación.
Asegurar alineación entre procesos, sistemas y requerimientos internos o regulatorios.

Competencias técnicas

Conocimientos en análisis y rediseño de procesos (BPM).
Experiencia en modelado de workflows y manejo de estructuras JSON.
Conocimientos básicos de automatización de procesos o flujos operativos.
Capacidad para entender requerimientos funcionales y llevarlos a procesos claros.
Manejo intermedio de Excel, PowerPoint, Word y herramientas de diagramación.
Deseable: nociones básicas de APIs, lógica condicional o integraciones.
Deseable: experiencia o familiaridad con la industria de pagos, fintech o servicios financieros.

Competencias personales

Pensamiento analítico y enfoque práctico.
Organización y buena administración del tiempo.
Comunicación clara, tanto escrita como verbal.
Proactividad y sentido de responsabilidad.
Atención al detalle.
Capacidad para trabajar con múltiples áreas y prioridades al mismo tiempo.

Nuestra oferta de valor:

Seguro de Gastos Médicos Mayores
Comedor
Fondo de Ahorro
Oportunidades de desarrollo

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This is a saved copy of a posting published elsewhere. Postings get taken down without notice — check the employer's site before applying. mentors.coach is not the hiring party.