ZipRecruiter

Log In

1

Computer System Validation Manager Jobs in Massachusetts

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Boston, MA · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Quality Management System and operational excellence. ESSENTIAL JOB FUNCTIONS * Lead Protocol ... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

next page

Showing results 1-20

All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Massachusetts

Computer System Validation Manager information

See Massachusetts salary details

$51.9K

$115.1K

$175.3K

How much do computer system validation manager jobs pay per year?

As of Aug 6, 2026, the average yearly pay for computer system validation manager in Massachusetts is $115,126.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,400.00 and $144,200.00 per year, depending on experience, location, and employer.

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

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Massachusetts? The most popular types of Computer System Validation jobs in Massachusetts are:
What are popular job titles related to Computer System Validation Manager jobs in Massachusetts? For Computer System Validation Manager jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Massachusetts look for? The top searched job categories for Computer System Validation Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Computer System Validation Manager jobs? Cities in Massachusetts with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Massachusetts as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $115,126 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 yesterday

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

#LI-TR1

Apply