Software Validation Engineer

This is a permanent position to work in our Cartago site, located in Zona Franca La Lima. Medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package.

Job function summary
The Software Validation Engineer will be responsible for the execution of software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test equipment, ensure compliance within external and internal requirements and ensure compliance to the quality management system.

Major areas of accountability

• Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.)
• Performing Software Release Testing, Installation, Operational and Performance qualification of production equipment, and production machines in alignment with the corporate instructions.
• Performing assessment about software changes and perform validation of software as appropriate
• Creation of software validation plans 
• Issuing, updating, and approving Process Risk assessments 
• Investigating abnormal test results (close collaboration with Quality Engineer, Production Support Engineers, engineering departments, project leaders and other stakeholders). 
• Troubleshooting validation issues (close collaboration with Quality Engineer, Production Support Engineers, engineering departments, project leaders and other stakeholders).
• Handling of Software validation and Risk assessments related Change Request tasks.
• Collecting, organizing, and documenting test data.
• Ensuring accurate records of all validation activities. 
• Support in the revision and approval of supplier documentation such as FAT and SAT etc according to Coloplast procedures.
• Performing activities in a timely manner.
• Performing with focus in the Corporate and department KPIs
• Participation in internal and external audits as required.
• Maintaining validation documentation throughout the validation life cycle.
• Comply with internal and external instructions and work discipline in connection with work.
• Participation on cross-functional teams related to projects for new machines, transfer machines, item extensions, critical and non-critical machine software changes, or any other project where software validation assessment or software validation activity is needed. 
• Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job
• Performing their job in compliance with the guidelines given
• Drawing attention to the manager to any difficulties in understanding or following the guidelines
• Drawing attention to inefficiency of the system
• Take responsibility for those safety aspects identified for the given position

Additional Areas of Accountability

• Performing their job in compliance with the guidelines given
• Drawing attention to the manager to any difficulties in understanding or following the guidelines
• Drawing attention to inefficiency of the system

Essential qualifications
Bach. degree in an Engineering field such as in Information technologies, systems, electrical, electronic or electromechanics fields.
Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
Knowledge in GAMP5 guidelines, FDA 21 CFR Part 820 and 11 desired
Experience in regulated industries (e.g., medical device industry).
Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
Min. 3 years of experience in quality, engineering, or production roles.
Fluent in both spoken and written English 

Preferred qualifications
Numerical skills and understanding of data analysis/statistical methods.
Understanding on PLC and HMI requirements  
Understanding on DS, FS, IO List and test requirements
Understanding on Unit, Integration and System test on production machine
Experience performing in validation roles
Mobile; capacity to travel abroad to received training and support transfer or activities such as FAT 

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 16 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.

Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a  _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.

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