1st Level Support, Access Control, Administrative Skills, Biology, Change Control, Change Management, Code of Federal Regulations, Configuration Management, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Data Quality, Disease, Documentation, External Audit, Healthcare, Identify Issues, Immunology, Improvement Metrics, Internal Audit, Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Systems, Master Data Management (MDM), Onboarding, Oncology, Ophthalmology, Process Validation, Quality Assurance, Research & Development (R&D), SAP, Standard Operating Procedures (SOP), System Operations, Systems Administration/Management, Systems Maintenance, Training Program, Urology, Validation Plan, Women's Health
Senior System Administrator
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
The System Administrator supports the implementation, operation, and maintenance of digital and computerized systems within a cGMP manufacturing environment. Acting as the primary link between Operations and IT, this role manages system configuration, user access, and master data for core applications such as SAP. The position ensures ongoing data integrity and 21 CFR Part 11 compliance across manufacturing and laboratory systems.
Role and Responsibilities
- Administer and maintain site computerized systems, including configuration, access control, and master data management.
- Serve as first-line support for user issues and coordinate system troubleshooting, change control, and periodic maintenance.
- Develop and maintain documentation including URS, configuration guides, validation protocols, SOPs, and training materials.
- Partner with IT, QA, and system vendors to manage system qualification (IQ/OQ/PQ), updates, and change management activities.
- Ensure systems operate in compliance with cGMP and data integrity standards; support internal/external audits and inspections.
- Support onboarding and training for system users and monitor compliance metrics for continuous improvement. Develop and maintain validation templates, SOPs, and training programs.
A
Astellas Pharma Inc
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.
2,500 to 4,999 employees
Biotechnology/Pharmaceuticals
https://www.astellas.com/us/