Computer System Validation Engineer (m/w/d)

Agidens is on the lookout for new talent! For our validation and compliance team, we are currently looking for a motivated Computer System Validation Engineer.

As a Computer System Validation Engineer within the Life Sciences team, you will help ensure the quality of the processes and systems used in drug production. This way, you help guarantee that only safe and effective drugs are produced!

WHAT WILL YOU DO?

• You write the validation documents for the system/software
• You carry out the validation activities
• You write a report with all the results of the execution and are also responsible for following up any open items

WHO ARE YOU?

Knowledge:

• You have experience working according to specific guidelines and regulations (e.g. GMP, GLP).
• You have already gained some experience in software applications in a GMP environment, e.g. document management systems, MES, ERP, LIMS, BMS, EBR, data history, etc..
• You have broad general ICT / automation knowledge (e.g. data exchange, data security, infrastructure, PLC, SCADA, MES systems, etc.).
• You are familiar with working according to GAMP5.
• You are aware of the current insights regarding 21 CFR part11.

Competencies:

• You are communicative and can adapt to different social situations.
• You are able to work with precision and enjoy working independently.
• You have good communication skills (both oral and written) in German and English.
• Above all, you have a great passion for technology.
• You have at least a Master’s degree in a technical area.
• You have min. 3-5 years of relevant work experience in the field of computer validation in a GMP environment.

WHAT DO WE OFFER?

• Exciting and varied tasks in the environment of the life science industry
• Development opportunities in an internationally growing company
• A dynamic team that attaches great importance to a collegial and open atmosphere
• Attractive employment conditions with an excellent occupational pension fund
• 1st class accident insurance (private)
• Additional benefits such as daily meal allowances
• Academy days and team building events
• International onboarding
• Flexible working hours, 5/6 weeks holiday
• Homeoffice - the possibility of working from home 

READY TO APPLY?