Dtech Engineer (m/f)

REFERENCE NUMBER:

401403/11

MY DUTIES:

-Shipping and monitoring solutions sourcing
-Translate user requirements into technical requirements / customize solutions for company needs if required
-Define testing thermal profile
-Conduct qualification
-Assess design and process risk and define monitoring strategy
-Provide user guidance and training across network
-Support regulatory submission
-Conduct periodic review and address recurring excursions/discrepancies and conduct RCA
-Conduct change impact assessment
-Support by internal and external Audit as DTech SME
-Support by decommissioning

MY QUALIFICATIONS:

-Bachelor degree in Life Science, Material Science or in Engineering
-Experience in a development project within a Pharma or Medical device organization
-Excellent collaborative and communication skills, communicate clearly and precisely in a well structured manner
-English essential, knowledge of German an asset
-Statistical knowledge (sample sizing, capability analysis) including DOE and statistical software such as Minitab
-Knowledge of testing methodologies and test standards used in GDP for thermal and mechanical shipping qualification
-Knowledge on OQ, and PQ and development of qualification protocols/reports for thermal and mechanical shipping qualification activities
-Knowledge regarding change and discrepancy management and in design and process risk management
-Knowledge regarding Health Authorities audit and regulatory filing
-Working knowledge of computer systems including TOPS, CAD or Solid Works, Microsoft tools including MS Project, and Adobe

MY BENEFITS:

-Pleasant working environment

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
Yves Fabien Deschamps

Reference number
401403/11

Contact
E-Mail: [email protected]