Senior System Administrator

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. Required Qualifications B.S. in biological sciences, chemistry, or related field with 5+ years (or M.S. with 3+ years) experience managing analytical or manufacturing computerized systems. Strong knowledge of

GMP, 21 CFR

Part 11, and data integrity principles. Experience with SAP system administration and validation. Familiarity with Windows environments, networks, and laboratory system integration. Excellent technical writing, communication, and troubleshooting skills. Demonstrated ability to work collaboratively and manage multiple priorities in a regulated setting Preferred Qualifications Experience in a fast-paced, high-growth biopharma or gene therapy environment. Experience with additional digital platforms (BMRAM, Labware LIMS, Tempo). Hands-on experience with instrument integration or data capture workflows. Location and Working Environment This is an on-site role working in a cGMP regulated manufacturing facility. On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%) What awaits you at Astellas?

Global collaboration:

Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

Real-world patient impact:

Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

Relentless Innovation:

Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

A Culture of Growth:

Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors Values:

Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors:

We come together as 'One Astellas,' working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution. Salary Range $94,570 - $135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Company fleet vehicle for eligible positions Referral bonus program #LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans