Computer System Validation Engineer (m/f)

REFERENZNUMMER:

285536/11

IHRE AUFGABEN:

-Manage, co-ordinate and develop validation deliverables for a new IS project
-Support and co-ordinate qualification and validation processes
-Support activities include, but are not limited to the preparation of validation/qualification plans, risk assessments, user requirement specifications, traceability matrix, testing (IQ, OQ/PQ), data migration, SOPs and change controls
-Facilitate the release of the regulated system for GxP production use in line with project timelines
-Support the problem solving of project deviations/errors and provide quality guidance on GxP regulatory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
-Participate in project teams as required
-Responsibility for defining test strategy, designing and developing test cases according to software requirements, architecture designs, and code of complex software systems
-Conduct validation training with project team, communicating deliverables, procedures and methods

IHRE QUALIFIKATIONEN:

-Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
-Profound industry experience in software engineering
-Software validation and equipment validation experience in a regulated industry (FDA 21 CFR 820, the Quality System Regulation and ISO 13485)
-Experience in GxP computerised systems
-Understanding of GAMP5 guidelines
-Validation experience with ERP, CCMS/CMMS, and quality systems is preferred
-Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11
-Strong knowledge of computerized system development life cycle approach is required

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist