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Thứ Ba, 14 tháng 4, 2015

Director Site Automation and IT - Genzyme - Allston, MA

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Director, Site Automation and IT-75001804-55433

Description

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.


Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.


Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.


IS Director, Site Manufacturing Systems and IT:


Position Summary:

The IS Director, Site Manufacturing Systems and IS/IT is responsible for supporting site manufacturing in collaboration with internal and external partners, regulatory and compliance groups and others in achieving the goals of manufacturing operations, enhancing site and interdivisional communication and alignment, facilitating site strategic planning and building consensus among key stakeholders on strategic and tactical decisions.


The incumbent is primarily responsible for:



  • Overseeing site Manufacturing Systems/IS department responsible for supporting all site shop floor systems (MES, PI data historian and other manufacturing IS systems) for 24x7 commercial manufacturing facilities with focus on the five pillars of manufacturing operations – Safety, Quality, Delivery, Cost and People.


  • Providing support to the Automation Engineering (AE) group (part of Site Engineering). The AE group will have a dotted line reporting relationship to the IS Director.


  • Maintaining partnerships with other site organizations, including Manufacturing, Facilities and Engineering, Manufacturing Science and Technology, QA and QC to establish and support site priorities and objectives.


  • Leading effort and processes to foster business partnerships through strategic planning including leading business changes to better leverage Manufacturing Systems/IS technologies and resources.


  • Driving strategic planning and business planning as they relate to Manufacturing Systems/IS, Enterprise System implementation including tracking of key metrics and communication.


  • Owning the site technology roadmap and major technology investments to align with business strategies and processes.


  • Executing on key commitments through completion of quality systems remediation, site projects and other large scale initiatives.


  • Overseeing integration and implementation of functional initiatives critical to site operational success.


  • Close coordination with the Automation Engineering group on projects and systems..


  • Interfacing with global Manufacturing Systems/IS organizations in executing Manufacturing Systems/IS projects and ensuring compliance to Sanofi, global and industry standards.


  • Interfacing and partnering with other Industrial IS sites to harmonize IS practices and processes and to share best practices and knowledge.


  • Translating global and site strategic initiatives into priorities and implementation plans for the function.


  • Overseeing, managing and reporting on site Manufacturing Systems/IS department budget.





Qualifications

Basic Qualifications


  • 10+ years of experience directing and/or managing Manufacturing Systems/IS systems and departments in a regulated environment





Preferred Qualifications:


  • Engineering degree, preferably MS in related disciplines


  • Experience supporting 24x7 commercial manufacturing sites


  • Experience operating in an FDA regulated environment (experience under consent decree preferred but not required) and strong quality system knowledge and understanding


  • Experience leading and managing, directly and indirectly, engineers and IS professionals


  • Experience with Manufacturing/Enterprise Systems/IS Technologies, including DeltaV, Werum MES, BMS, PLC and SCADA systems, data historian and reporting systems, quality systems, laboratory systems as well as SAP, EDMS, LIMS, etc.


  • Experience in the application of industry standards and regulations such as GAMP, ISA S95 and S88 standards, 21 CFR Part 11 and Annex 11 #LI-GZ





Job : Information Solutions

Primary Location : United States-Massachusetts-Allston

Job Posting : Apr 9, 2015, 3:05:43 PM


Shift : Day Job

Job Type : Regular

Employee Status : Regular




Genzyme - 4 days ago - save job


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