CSV Engineer

Beschreibung

CSV Engineer

German Fluent

English Fluent

CSV Engineer

Your tasks are:

* Support in various qualification and validation projects

* Execution of validations on ERP, MES, IT, monitoring and automation systems in the GMP environment (pharmaceuticals)

* Creation of CSV plans and assessments, URSs, functional specifications, risk analyzes, SOPs, changes and CAPAs

* Perform gap assessments

*Ensuring compliance with regulatory requirements

* Experience in concept development and definition of workflows for data governance and CSV

* Raising awareness of data integrity and the importance of CSV

Your profile:

* Completed (technical) university degree in the field of process engineering, computer science, pharmaceutical technology or comparable training

* Mind. 5 years of experience in the field of CSV / Data Integrity for relevant IT systems (ERP, MES, LIMS, etc.)

* Experience in plant qualification in a GMP regulated environment is an advantage

* Know-how of the regulatory requirements acc. GAMP5, FDA CFR part 11, EU GMP Annex 11, etc.

* Willingness to travel available

* Very good spoken and written German and English skills

* Enjoy working independently

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.