"Alerted.org

Principal Computer System Validation Specialist

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 **Principal Computer System Validation Specialist** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**

Purpose:

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.

Essential Job 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.

Quantitative Dimensions:

The Principal Computer System Validation Specialist ensures the validated state and regulatory compliance of computerized systems supporting GxP operations. This role influences the quality, reliability, and data integrity of systems critical to manufacturing, laboratory, and quality processes. They will contribute to efficient project execution and audit readiness through collaboration with internal stakeholders and external vendors.

Organizational Context:

The Principal Computer System Validation Specialist will typically report to the Associate Director, Manufacturing Technical Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Qualifications

Required:

+ 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, LabWare, 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:

+ 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.

**Salary Range:** $103,600-148,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

+ 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