Software Validation Engineer

Flex creează produse extraordinare pentru clienţi, care aduc valoare şi îmbunătăţesc vieţile oamenilor. Cu o istorie de manufacturiere şi realizare de produse de peste 50 de ani, în centrul activităţilor şi operaţiunilor noastre se află comunitatea Flex de ~170.000 de membri în 30 de ţări.

- Degree in Electronics / Computers / Automation or equivalent;
- Experience in IT/Medical manufacturing industry;
- Relevant experience in documentation, test, implementation, development and configuration control systems and management of production process;
- Basic knowledge of database environments (MS SQL Server 2016 and above considered a plus), development skills;
- Analytical thinking, organizational skills and flexibility;
- Ability to define problems, collect data, establish factors and draw accurate conclusions;
- Communication and presentation skills;
- Proficient level of English

- You will communicate with Software Developers, MES Engineers and Key users to technically understand the software and how it will be used. Based on understanding of the software provide to internal teams the level of documentation and validation required to be compliant with FDA requirements;
- Will collaborate with multicultural teams to understand the validation plan and FDA requirements;
- Write the required validation documents (requirements, specifications, risk analysis, protocols, reports, etc.);
- Be able translate technical information from software coders and MES engineers into requirements, specifications, workflows, and procedures;
- Participate in design and development work instructions related to job production tracking system;
- Assure password security, data integrity and security of system files related to production systems that interact;
- Record management and follow Service Now tickets in its area of responsibility;
- Interacts effectively with other levels of support within the organization;
- Answers to Support requests coming out of internal customers