Principal Computer System Validation Specialist

Astellas Pharma; Westborough (MA); Hybrid; USD 105,280 - 150,400; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

PTO & Holidays

401k match

Life Insurance

Bonus Program

Company vehicle

Referral bonus

Job summary

Astellas Pharma in Westborough, MA seeks a CSV Lead to develop, execute and maintain the validation strategy for GxP computerized systems supporting manufacturing, laboratory and quality operations. This role ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 while aligning with corporate best practices.

The expert will author and review CSV deliverables, collaborate with cross‑functional teams, and drive continuous validation across upgrades and configurations to ensure data

Qualifications

• Bachelor’s degree in science/engineering or related field with 5–8 years in CSV or IT quality.
• Deep knowledge of GxP, GAMP 5, and 21 CFR Part 11/Annex 11 compliance.
• Experience validating enterprise and lab systems (LIMS/MES/QMS/ERP).

Responsibilities

• Lead validation projects for GxP computerized systems (manufacturing, lab, quality).
• Create and review CSV deliverables: plans, URS, FS, DQ, IQ/OQ/PQ, reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and SOPs.
• Collaborate with IT, QA, Manufacturing, Lab, and vendors on scope & strategy.
• Lead impact assessments for upgrades, patches, and configurations.
• Support data integrity initiatives and periodic review programs.
• Manage audit readiness and support FDA/EMA inspections.
• Develop and maintain validation templates, SOPs, and training.

Skills

GxP principles

GAMP 5

Technical writing

Project management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in CS/Engineering/Life Sciences

Master’s Degree (MBA/MIS) preferred

Tools

LIMS

MES

QMS

ERP

OSI PI

Empower

SAP

LabWare

Job description

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.

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, LabWare).
• 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. Hybrid work 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, Impact. 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 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.