Principal Computer System Validation SpecialistPurpose & 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, 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 EnvironmentThis 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.
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
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