Auditing, Best Practices, Biology, Code of Federal Regulations, Computer Systems, Corporate Policies, Cross-Functional, Customer/Client Research, Data Quality, Disease, FDA (Food and Drug Administration), FDA Requirements, GxP, Healthcare, Immunology, Laboratory Operations, Maintain Compliance, Manufacturing, Manufacturing Systems, Oncology, Ophthalmology, Process Validation, Quality Assurance, Research & Development (R&D), Risk Analysis, Software Patches, Software Upgrades, Standard Operating Procedures (SOP), System Validation, Systems Administration/Management, Training Program, Urology, Validation Plan, Women's Health, Writing Skills
Principal Computer System Validation Specialist
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 Computer System Validation (CSV) Lead is responsible for developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting manufacturing, laboratory, and quality operations. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices.
Role and Responsibilities
- Lead the planning and execution of validation projects for GxP computerized systems (manufacturing, laboratory, and quality).
- Author and/or review CSV deliverables including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), IQ/OQ/PQ protocols, and summary reports.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company SOPs and policies.
- Collaborate with cross-functional teams (IT, QA, Manufacturing, Lab, and vendors) to define validation scope, strategy, and deliverables.
- Lead impact assessments for software upgrades, patches, and configuration changes; ensure continuous validation state is maintained.
- Support data integrity initiatives and periodic review programs.
- Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.).
- 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/