Job Summary:
Astellas Pharma is a global life sciences company dedicated to innovative science for patient value. The Senior System Administrator will support the implementation and maintenance of computerized systems in a cGMP manufacturing environment, ensuring compliance and data integrity while managing user access and system configuration.
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.
Qualifications:
Required:
• 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:
• 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.
Company:
Astellas Pharma develops and commercializes prescription medicines across therapeutic areas. Founded in 2005, the company is headquartered in Tokyo, JPN, with a team of 10001+ employees. The company is currently Late Stage.