Systems Administrator / Senior Systems Administrator - MES
|Posted on:||Friday, July 13, 2018|
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: Responsible for the overall system maintenance and on-going support of the Manufacturing Execution System (MES). The individual provides configuration and support services to the MES to meet end-user needs. Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a validated state.
Essential Duties and Responsibilities include, but are not limited to the following:
• Provides MES configuration and support services to meet end-user needs.
• Processes system change controls, documents configuration, and writes test plans to ensure that the MES remains in a validated state.
• Coordinates the needs of functional departments and establishes priorities for MES requirements gathering, system design and implementation.
• Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle, including User Requirement Specifications, Functionality Specifications, and Configuration Specifications.
• Reviews company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess impact to MES related IT infrastructure and processes.
• Works with Validation and Quality Assurance departments to ensure MES is implemented following development life cycle approach.
• Provides end-user support for the MES including troubleshooting problems at the application server level.
• Performs User Management and system administration functions in MES.
• Recommends and installs systems updates, patches, services packs, and hot fixes.
• Monitors applications for readiness, availability, and performance trend analysis.
• Maintains disaster recovery environment and ensure periodic testing is performed.
• Logs application support incidents and prepares appropriate resolution plans.
Knowledge and Skills:
Education and Experience:
Relevant Manufacturing Execution Systems include, but are not limited to: