System Administrator - Urgently Hiring!

System Administrator

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a System Administrator opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose :

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 LIMS and EBR. The position ensures ongoing data integrity and 21 CFR Part 11 compliance across manufacturing and laboratory systems.

Essential Job 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.

Quantitative Dimensions :

This role directly impacts digital system uptime, data integrity, and compliance readiness. The position collaborates closely with IT technical leads to ensure systems operate reliably and efficiently in a validated state.

Organizational Context :

Reports to the Associate Director, Manufacturing Technical Support. Collaborates cross-functionally with IT, QA, Validation, and Manufacturing teams to maintain compliant, validated, and reliable systems in support of Astellas mission.