Job Responsibilities/Department Description:
Prepare detailed specifications for new business systems, programs or modification to existing systems. This includes URS, GxP impact assessment, risk analysis, PUMA methodology, etc. Evaluate and implement centralized data management system for multiple groups within organization. Program, maintain and troubleshoot data storage, archival and restore function for the department including changes and resolution of issues related to data management systems. Participate in global technology effort on data acquisition and data management, including sample coding, sample flow, data evaIuation/data mining, advanced analytics, modeling/simulation technology and related statistics/trending and data storage; interface with global Advanced Data Analysis and Predictive Process Science Skill Center. Maintain and perform site admin role for data and knowledge management systems, manage access to scientific computerized systems, and interface with ITS support groups. Represent the organization in providing solutions to difficult technical issues associated with specific IT/IS projects. Write relevant SOPs related to scientific application systems in preparation for their implementation. Maintain department web portal/SharePoint; install scientific application software; assist in troubleshooting scientific applications. Work is performed under general direction. Independently determines and develops approach to solution.
Bachelor's degree and 5 - 8years of experience or Master’s degree and 3 – 6 years of experience. Experience with Microsoft Word, Excel, Project, and Visio.
Advanced skills with data management, data analytics and modeling. Demonstrated ability to analyze stakeholders needs and skills in teamwork and communication with local and global teams. Experience with applicable US and worldwide regulatory requirements for the biotechnology industry (EU Annex 11, 21CFR Part 11, etc.) and GMP regulations and good documentation practices is a plus.