Verification Engineer with Expert Knowledge in Statistics (m/f)

REFERENCE NUMBER:

374639/11

MY DUTIES:

-Translate cGMP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) in practical lab processes (e.g. test method validation and transfer, discrepancy management and OOS, change management, complaints)
-Develop robust test method validations
-Lead and track change control activities for test methods and lab processes
-Define appropriate statistical techniques and acceptance criteria
-Author of protocols, rationales and reports
-Perform Risk Assessment
-Analyze test data: design capability, regression analysis, capability analysis
-Write, review, approve design verification plans, protocols and reports, support development of rationales justifying chosen approaches
-Lead and track management of unexpected events for these medical devices/combination products within cGxP regulated area
-Facilitate planning and execution of early experimental testing
-Support management during internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses

MY QUALIFICATIONS:

-Technical/Engineering degree education, with additional statistical qualification, Bachelor or advanced degree in Engineering or Science discipline (pharmaceutical/biomedical/materials science, manufacturing or process control engineering or a related field)
-Excellent practical knowledge of Common Statistical Tools and Techniques
-Excellent knowledge of Measurement System Analysis, Data trending, Software for Statistics, Root Cause Analysis
-Excellent command of spoken/written German and English
-Prior working experience in characterization of medical device/combination products, special/innovative packaging, or compact, complex, multi-material hand-held products is beneficial
-Knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices is beneficial

MY BENEFITS:

-Pleasant working atmosphere

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Tina Maric

Reference number
374639/11

Contact
E-Mail: [email protected]