Career Opportunities

Systems Administrator / Senior Systems Administrator - MES

Posted on: Friday, July 13, 2018
Organization: Regeneron
Location: Rensselaer, NY
Description:
Position Summary
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.
Requirements:

Knowledge and Skills:

• Knowledge of SQL, Oracle and relational database concepts required.

• In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements preferred.

• Knowledge of biopharma business processes strongly preferred.

• Requires logical troubleshooting and problem solving skills.

• Excellent analytical, written and oral communication skills are a must.

• Excellent interpersonal skills with strong customer service focus.

• Ability to maintain integrity and honesty at all times.

• Continuously drive to improve processes for improved performance.

Education and Experience:

• Requires BS/BA in Computer Science or equivalent degree discipline; may substitute relevant industry experience for educational requirement.

• Requires 5 years of experience in a life sciences manufacturing environment or other regulated manufacturing environment

• 3+ years of experience providing technical support with MES strongly desired

Relevant Manufacturing Execution Systems include, but are not limited to:
- Werum Pas-X
- Emerson Syncade
- Rockwell Automation PharmaSuite
- Siemens SIMATIC IT

Title level will be determined based on skills and experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.

Apply Now

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