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Computer System Validation Jobs in Shrewsbury, MA

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Computer System Validation information

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$10

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How much do computer system validation jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for computer system validation in Shrewsbury, MA is $55.34, according to ZipRecruiter salary data. Most workers in this role earn between $42.60 and $65.62 per hour, depending on experience, location, and employer.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

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

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
What job categories do people searching Computer System Validation jobs in Shrewsbury, MA look for? The top searched job categories for Computer System Validation jobs in Shrewsbury, MA are:
What cities near Shrewsbury, MA are hiring for Computer System Validation jobs? Cities near Shrewsbury, MA with the most Computer System Validation job openings:
Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Shrewsbury, MA as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $115,108 per year, or $55.3 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 1 hour 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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