Principal Computer System Validation Specialist

** 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

** 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.

** Required Qualifications*
* + Bachelor's degree in computer science, Engineering, Life Sciences, or related discipline.

+ Minimum 5-8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry.

+ Deep understanding of GxP Principals, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance.

+ Experience leading validation of enterprise and laboratory systems such as LIMS, MES, QMS, ERP, or data historians (e.g., OSI PI, Empower, SAP, Lab Ware, etc.).

+ Strong technical writing and documentation skills with attention to detail.

+ Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.

** Preferred Qualifications*
* + Master's Degree (MBA, MIS, or related field)

+

Experience with cloud-based or SaaS GxP systems

+ Familiarity with data integrity, cybersecurity, and IT infrastructure qualification (IQ of servers, networks, virtualization).

+ Project management or Lean Six Sigma certification **.*
* ** Location and Working Environment*
* This position is based in Westborough, MA.  Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

** 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*
* $105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to…