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Computer Systems Validation Jobs in Massachusetts

Zifo

Validation Analyst

Norwood, MA · On-site

Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...

Zifo

Validation Analyst

Norwood, MA · On-site

Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...

Zifo

Validation Analyst

Norwood, MA

Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA ... Provide support to the QC labs for the Benchtop and Enterprise computer systems as system ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA · On-site

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...

Moderna, Inc.

Sr. Engineer, GxP Systems

Norwood, MA · On-site

$121K - $194K/yr

Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification protocols and writing system configuration specifications, risk assessments, and administration ...

Moderna Therapeutics

Sr. Engineer, GxP Systems

Norwood, MA · On-site

$121K - $194K/yr

Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification protocols and writing system configuration specifications, risk assessments, and administration ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA · On-site

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...

Genezen

Validation Engineer II/III (CSV)

Lexington, MA

$90K - $130K/yr

This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test ...

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How much do computer systems validation jobs pay per hour?

As of Jun 5, 2026, the average hourly pay for computer systems validation in Massachusetts is $59.32, according to ZipRecruiter salary data. Most workers in this role earn between $45.67 and $70.34 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Computer Systems Validation, and why are they important?

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

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

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
What are popular job titles related to Computer Systems Validation jobs in Massachusetts? For Computer Systems Validation jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer Systems Validation jobs in Massachusetts look for? The top searched job categories for Computer Systems Validation jobs in Massachusetts are:
Computer Systems Validation jobs near you
Infographic showing various Computer Systems Validation job openings in Massachusetts as of May 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, 1% Temporary, and 1% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $123,391 per year, or $59.3 per hour.

Senior Computer Systems Validation (CSV) Specialist

Karl Storz GmbH & Co. KG

Charlton, MA • On-site

Other

Posted 10 days ago

Job description

Senior Computer Systems Validation (CSV) Specialist

Location: Charlton, MA or Goleta (Santa Barbara), CA

Join a global leader in medical technology and help shape the future of digital quality and compliance. KARL STORZ is a family-owned, innovationdriven organization known for advancing minimally invasive surgery and delivering worldclass endoscopy solutions for more than 80 years. With a strong culture of collaboration, integrity, and continuous improvement, KARL STORZ North America offers the opportunity to make a meaningful impact in healthcare while growing your career in a supportive, peoplefirst environment.

 

About the Role

We are seeking a Senior Computer Systems Validation (CSV) Specialist to lead and manage nondevice software validation activities across our U.S. manufacturing and distribution sites. In this highly visible role, you will collaborate with global teams, ensure compliance with regulatory requirements, and drive bestinclass validation practices that support our Quality Management System and operational excellence.

 

What You'll Do

  • Lead and manage the global CSV process for U.S. sites, partnering with crossfunctional and international teams.
  • Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, and internal standards.
  • Develop, review, and oversee validation lifecycle documentation, including plans, protocols, risk assessments, and reports.
  • Analyze validation data, identify gaps, and support investigations and corrective actions.
  • Manage vendors and consultants providing CSV services.
  • Maintain validation tracking databases and contribute to process improvement initiatives.
  • Represent CSV and IT during audits and regulatory inspections.

 

What You Bring

 

Required:

  • 7+ years of CSV experience, including 5+ years in a regulated industry (medical device, aerospace, automotive, etc.).
  • Associate degree in Applied Science or equivalent experience/certifications.
  • Strong knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.
  • Expertise in software validation standards, technical writing, and documentation control.
  • Experience managing validation projects and collaborating across technical and business teams.
  • Exceptional organizational, communication, and technical writing skills.
  • Ability to manage multiple complex projects independently.
  • Ability to travel up to 10%

 

Preferred:

  • Bachelor's degree in software engineering, computer science, IT, or related field.

 

Why KARL STORZ

  • Work for a respected global medical technology leader with a strong commitment to quality and innovation.
  • Join a collaborative culture that values professional growth, continuous learning, and crossfunctional teamwork.
  • Contribute to solutions that directly support patient care and healthcare advancement.
  • Enjoy competitive benefits, stability, and the opportunity to influence global processes.

 

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