Software Validation Engineer (m/f)

REFERENZNUMMER:

313140/1

IHRE AUFGABEN:

-Support software validation protocols and software validation performance qualification summary reports
-Generation and revision of validation protocols, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports
-Testing and evaluation of software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ)
-Evaluation of validation/requalification
-Maintain and assist in establishing standardized methods
-Procedures for software, process, and test method validations and ensures standardized methods are implemented and followed

IHRE QUALIFIKATIONEN:

-Bachelor’s or Master's degree in Engineering
-Knowledge of ISPE GAMP, FDA 21 CFR Part 11, EU Annex 11, and ISO 13485
-Direct experience in performing software validation(s)
-Experience in the definition and support of appropriate AQLs and sampling plans and ensuring that they are established with the appropriate documented rationale
-Assessing and documenting the needs for improvement
-Profound experience within the Medical Device industry
-Good understanding in technical oral/written English and German

WEITERE QUALIFIKATIONEN:

Software tester