BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 25,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public.
BD is an Equal Opportunity/Affirmative Action Employer
About us
Description
As an associate reporting into IT, the incumbent will be required to work collaboratively with across Global IT associates, Corporate Quality Management and Corporate Regulatory Affairs on both the validation of new systems as well as the improvement of existing IT Quality Processes and/or practices. In this highly visible role, the Validation Engineer will be required to provide validation support and guidance on a variety of system validation projects and production environment changes. Additionally, the incumbent must be capable of identifying and communicating any FDA/ISO/SOX compliance risks within existing IT work processes and/or existing production systems. The incumbent MUST be a subject matter expert of the SDLC methods as they relate to Computer System Validation, IT Quality Systems and Technology in general. Scope of business applications to be potentially supported will range across GMP, GCP and GLP regulatory areas. Scope of role is additionally inclusive of both application and infrastructure validation responsibilities. Further responsibilities include supporting and maintaining the validated state of Validation Document Mgmt. tool set.
Qualifications
* BS / BA in Information Technology &/or Related Science field * Must have a minimum of 3+ years System Validation & QA Experience * Experience in working in the FDA/ISO regulated environment is a MUST * Experience validating ERP SAP, Content Mgmt. system and Infrastructure required.
Job Information Technology
Primary Location US-New Jersey-Franklin Lakes
Shift First Shift / Day Job
Relocation Available No
Nearest Major Market: New Jersey Job Category: Engineering, Scientific, Engineer, Medical Device Engineer, Healthcare, Medical Device, Medical Technology, Medical Research, Legal, Law, Compliance, Regulatory Affairs, Quality, QA, Quality, Quality Manager, Research, Research, Technology, SAP, ERP, Quality Assurance
