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.
Learn more at www.genzyme.com
Job Title MES Support Engineer (MES SME)
Department Description:The MQO MES team provides leadership for MES implementations and projects throughout the manufacturing organization and interfaces with IT, Quality Business Solution groups and infrastructure.
Oversees, facilitates and supports MES operations at Corp. Operations Manufacturing sites.
Understands / identifies demands and responds on treats & opportunities
Key contacts:MES Project team members, MES site support, SME Business Process and MQO MES co-workers, MES supplier
General Purpose of the job:
This role works closely with the Corp. Operations Manufacturing Sites to provide in-depth knowledge and hands on during the MES project implementation and operational phases, executing tasks and providing tier 3 support related to the MES Business Services Suite.
Core activities / Areas of result
- Provides in-depth subject matter expertise in MES functionality
- Provide in-depth subject matter expertise in MES MBR design
- Provides in-depth subject matter expertise in MES configuration
- Understands business processes and systems in Manufacturing and Quality like MES, ERP, CAPA, LIMS, ECM, Training systems, etc and their integration and interrelation in a typical GMP environment
- Understands Automation
- Understands systems interfacing and integrations technologies and processes
- Understands (GAMP5) validation principles
- Executes tasks according to best in class documented guidance for MES system management towards Corp.Operations Manufacturing sites:
- Configuration Management
- Performance Management
- Change Management
- Release Management
- Provides Tier 3 (MES) support for severe issues towards Corp. Operations Manufacturing sites within the agreed framework of Service Level Agreements
- Coordinates and executes activities related to Documentation, MBR design and MES system configuration according to the Project Management standards
- Coordinates and executes tasks within the MES project implementation and operational phase using adequate quality management standards and systems related to MES Business Services Suite in order to improve and consolidate 'best in class' performances.
- FinanceWorks within the framework of the MES Project implementation budgets.
- Executes the successful completion of tasks within the MES project implementation and operational phase. Erroneous decisions or recommendations would typically result in failure to achieve project objectives or timely restoring "business as usual".
Key Performance indicators
- Effective (on-time, on-spec, on-budget) and customer satisfaction project tasks completion
- Effective (on-time, on spec, on-budget) of operational support measured in customer satisfaction within the agreed framework of Service Level Agreements
Skills & Knowledge
- Demonstrates a clear understanding of MES functionality
- Demonstrates experience help-implementing MES systems in a GMP environment
- Hands on mentality and a supportive nature
- Minimum of 2 - 3 years of MES Subject Matter Expert relevant experiences both in projects and operational support;
- System knowledge related to MES functionality;
- Participation in MES related projects under time constrains and high impact risks
- Preferred QualificationsFamiliar with complex GMP environments, understanding of validation principles;
- Ability to communicate complex issues within a multicultural organization
- Excellent analytical and communications skills;
- Ability to work under time-pressure, while staying client focused and result driven;
- Regular travel.
- Bachelor's degree
- Werum PAS- X
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