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Application Specialist III
Ref No.: 15-03758
Location: Framingham, Massachusetts
The project involves the implementation of a Statistical Process Control (SPC) data analytics solution for Sanofi Industrial Development organization and manufacturing sites globally. The initial deployment will cover the human vaccines and rare diseases divisions of Sanofi (Sanofi Pasteur and Genzyme respectively) in several sites located in France, Canada, United States, China, Argentina, Mexico and Brazil.



The solution will read data from several sources (Process Data Warehouse, Shoop Floor Data tool and excel / JMP files for historical data) and display dynamic dashboards with identified KPI and analytics information as configured for the process and the parameter. The solution will continuously analyze new data, apply specified rules (such as Western Electric) and generate alert notifications. It will generate site specific and worldwide reports based on defined schedule or on-demand. The solution will use Statistica for the back-end components, processing, storage and security and utilize JMP for the dynamic dashboards and end user interface.


RESPONSIBILITIES & DELIVERABLES:


Work closely with Sanofi cross functional business users and source system SMEs to identify the high level business requirements and translate them into detailed user requirements utilizing use cases, quality of service requirements and implementation requirements for project Work closely with all project stakeholders, developers, software vendor SAS and system integrators to provide the functional requirements and the functional design Overall and detailed design of the system interfaces, processing, storage and display JMP stream lead for the activities around designing, developing, validating and implementing the SPC solution Own configuration and development of JMP components to meet the requirements of the solution, including JSL programming Communicate and manage change in requirements over the project life cycle; partner with the project manager to assess the impact on the project scope Identify and manage areas of risk related to requirements and design Work closely with the business users to make sure that all master data and metadata as it relates to the solution is setup accurately Generate test data and test scenarios, execute the generated test scripts, record the deviations and drive their resolution and closures.
Contribute to the creation or update of the business and IS related standard operating procedures (SOPs), standard work instructions (SWIs), training materials, etc. as needed for implementation of the new functionality and corresponding processes Knowledge transfer with the Sanofi resource(s)


Skills:

GENERAL EXPECTATIONS










Documentation will be consistent with Sanofi IS standards as provided.
Service Provider will meet with the Project Manager weekly to review deliverables of the previous week, confirm expectations for the current week and address any concerns. Service Provider will provide a status report for the preview. Deliverables as per agreed upon work plan will be tracked.



The Service Provider shall ensure that each change is approved and shall execute all tasks based on the project plan The Service Provider shall ensure that the solution being provided follows standard pharmaceutical industry practices The Service Provider must report incidences and occurrences which impact or have the potential to impact user access to IT services, or which pose threats to health/safety or security in accordance with regulations, directives, policies and procedures



The Service Provider will be on site when working on the project at the Genzyme campus in Westborough, MA.
Some regional and international travel may be necessary.
The Service provider will work 40 hours/week. Overtime must be pre-approved.


REQUIREMENTS AND QUALIFICATIONS



The candidate must possess the following skills and experience:

Bachelors degree: Computer Science, Mathematics or other Business / Sciences Minimum 7 years of experience in implementing enterprise software systems Strong knowledge of statistical methods, principles and SPC charts Demonstrable hands-on experience using the JMP suite of analytics software products and solutions Recent and hands-on experience with JSL scripting Ability to handle expression syntax in JSL scripts Experience writing and understanding SQL queries Experience using source code control systems such as SVN Experience with validation of IS computer systems in an FDA regulated environment; Experience with 21 CFR Part 11 Compliance Strong consulting service delivery background from project scoping through support and maintenance Strong analytical, problem solving skills and attention to detail Understanding of software development lifecycle and master data management principles Experience with IS systems interfaces and experience working with global projects is desired Understanding of document management principles Demonstrated technical writing and oral communications skills This person will work directly with cross-functional teams and must have strong interpersonal skills

Education: Bachelors degree: Computer Science, Mathematics or other Business / Sciences