Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground
Computer System Validation (CSV) Engineer JNJKJP (m/f)
Reference: -en
Start: asap
Duration: 10 MM++
Main tasks:
- Computer Systems validation activities
- Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within EMEA
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Creating specific computer system validation documentation
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Planning and implementation of qualification / validation activities and projects of existing computer systems according to company guidelines and expectancies
- Performing CSV trainings
Main qualifications
- Higher education (Engineer or similar) and background in IT and at least solid work experience
- Responsibility in similar position or extended experience as executer required
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Experience in CSV system development life cycle is required
- Background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing
- Validation experience with ERP, MES, LIMS, and Quality Systems is preferred
Main advantages:
- A very renowned company
- You will work in an international environment
- A highly motivated team and an open way of communication
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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