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Computer System Validation Specialist Jobs (NOW HIRING)

Validation & Engineering Group, Inc

PR · On-site

Computer System Validation (CSV) Specialist Project summary: * Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company ...

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Computer System Validation Specialist information

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$10

$54

$86

How much do computer system validation specialist jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for computer system validation specialist in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a computer system validation specialist, and why are they important?

To thrive as a Computer System Validation Specialist, you need expertise in computer science, regulatory compliance (such as FDA 21 CFR Part 11 and GxP), and a background in life sciences or IT, often supported by a relevant bachelor's degree. Familiarity with validation lifecycle documentation, risk management tools, and computerized system validation (CSV) software is essential. Strong analytical thinking, attention to detail, and effective communication skills help ensure thorough documentation and collaboration across departments. These abilities are crucial to maintain regulatory compliance, data integrity, and smooth system implementation in highly regulated industries.

What are some common challenges faced by computer system validation specialists during project implementation?

Computer System Validation Specialists often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating with cross-functional teams like IT, QA, and business users. Navigating diverse documentation requirements and handling unexpected changes to system specifications can also be demanding. Effective communication, attention to detail, and proactive risk management are essential to successfully overcome these obstacles and deliver compliant, validated systems.

What does a computer system validation specialist do?

A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality. As a CSV specialist, your responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. You also review test results and identify areas of improvement to implement changes. Other duties include providing technical expertise to customers and the validations department while communicating the validation plan and creating protocols. You may also ensure that each product is compliant with Current Good Manufacturing Practice (CGMP), Good Automated Manufacturing Practice (GAMP), and Code of Federal Regulations.

What does a computer system validation specialist do?

A Computer System Validation Specialist ensures that computer systems used in regulated industries, such as pharmaceuticals or medical devices, comply with regulatory requirements and function as intended. They develop and execute validation protocols, document processes, and work closely with quality assurance and IT teams to maintain compliance. Their work helps guarantee data integrity, product quality, and patient safety by ensuring systems are reliable and audit-ready.

What is the difference between Computer System Validation Specialist vs Quality Assurance Specialist?

AspectComputer System Validation SpecialistQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, CSV-specific trainingISO 9001, Six Sigma, QA certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, software, healthcare sectors
Employer & Industry UsageRegulated industries requiring compliance documentationBroadly used across industries for process quality

The Computer System Validation Specialist focuses on ensuring computer systems meet regulatory standards through validation processes, primarily in regulated industries like pharma and biotech. In contrast, the Quality Assurance Specialist oversees overall quality processes, including audits and compliance, across various sectors. While both roles emphasize compliance and documentation, the CSV Specialist is more technical and specific to computer systems validation, whereas the QA Specialist has a broader scope in quality management.

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Computer System Validation Specialist jobs near you
Infographic showing various Computer System Validation Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Principal Computer System Validation Specialist

Astellas Pharma, Inc.

Westborough, MA • On-site

$105K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 4 days ago

Job description

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.

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 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 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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