Description
CSV EngineerGerman 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.