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Computer Systems Validation Jobs in Massachusetts

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

... Computer System Validation experience Company : Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services. Founded in 2014, the ...

Genezen

Senior CSV Validation Engineer

Lexington, MA · On-site

Required : • A minimum of a Bachelor's degree in Engineering, Computer Science or related discipline • 7+ years of Computer System Validation experience • In depth CSV experiences including as ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

SOKOL GxP Services

Validation Engineer

Devens, MA · On-site

Author and execute computer system validation scripts using ALM or paper-based methods. * Own change controls related to qualification of QC instruments and associated software. * Update the asset ...

SOKOL GxP Services

Validation Engineer

Devens, MA · On-site

Author and execute computer system validation scripts using ALM or paper-based methods. * Own change controls related to qualification of QC instruments and associated software. * Update the asset ...

SOKOL GxP Services

Validation Engineer

Devens, MA · On-site

Author and execute computer system validation scripts using ALM or paper-based methods. * Own change controls related to qualification of QC instruments and associated software. * Update the asset ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV experiences including as a Validation lead Essential The ability to communicate with employees of all ...

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Computer Systems Validation information

See Massachusetts salary details

$11

$59

$93

How much do computer systems validation jobs pay per hour?

As of Jul 1, 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 is the work of computer system validation?

Computer Systems Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of a CSV engineer?

A Computer Systems Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications in validation or quality assurance and proficiency with regulatory standards like FDA or GxP can influence compensation levels.

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.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements such as FDA or EMA guidelines. The field offers steady employment opportunities, especially for professionals with certifications like GAMP or 21 CFR Part 11 knowledge.

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 is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools such as SystemVerilog and UVM.

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 June 2026, with employment types broken down into 47% Full Time, 47% Part Time, 3% Temporary, and 3% 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.
Global Computer Validation Specialist

Global Computer Validation Specialist

Global Channel Management, Inc.

Marlborough, MA

$40/hr

Contractor

Posted 24 days ago

Job description

Company Description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation.  Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function.  Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. 


Job Description

Hands on position responsible for authoring test scripts and other
CSV documents required for the validation of GAMP 5 Category 4
(configurable off the shelf) computer systems.  Candidates should be
familiar with COTS systems used for clinical development and quality
activities in a pharmaceutical environment.  Work with business users
and Information Technology to ensure the systems remain in a validated
state through appropriate change control procedures. May require
participation in early morning and/or evening teleconferences with
global project teams.

  1. Create
    and/or review computer system validation test scripts, validation
    schedules, risk assessments, requirement specifications, protocols and
    reports, traceability matrices, and validation summary reports according
    to the timelines in the project plan.  Review applicable procedures and
    system training manuals as applicable. Participate in project team
    meeting. (85%)
  2. Document
    requirements for business requirements, system security, user roles,
    workflows, data flows, GxP requirements and how these systems fit into
    the larger IT infrastructure. (10%)
  3. Work
    with IT and User Groups to: (a) evaluate change control requests, (b)
    assess regulatory risk associated with such requests and (c) determine
    the corresponding validation requirements for such changes. (5%)
Qualifications
  • 2 - 3 years experience writing CSV test scripts, protocols and summary reports in global environments
  • Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline. 

Knowledge and skills (general and technical):

  • Sufficiently
    knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best
    practices for computerized system validation to complete tasks
  • Experience working with global teams particularly with team members from Japan
  • Understands lifecycle approach as well as risk based approach to validation
  • Generally familiar with GXP regulations particularly in the GCP and Quality areas
  • Able to work both independently and as a member of a cross-functional project team
  • Good written and oral communication skills
  • Good problem solving skills
  • Microsoft products such as Word, Excel, Project, and Visio.
  • Familiar
    with Information Technology principles, functionalities and
    capabilities of computer systems; and how computer systems relate to and
    integrate with larger corporate IT infrastructures
Additional Information

$40/hr

6 MONTHS +

Global Channel Management logo

About Global Channel Management

Sourced by ZipRecruiter

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Global Channel Management understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at the same time requiring the best talent for the job. GCM's Ownership and Management teams have extensive Staffing, Recruiting, HR and Executive Leadership knowledge, Experience and Expertise. Our Understanding and Commitment to our Client's Satisfaction are key reasons GCM has been successful in establishing long term relationships.

Industry

Recruiting and staffing services

Company size

11 - 50 Employees

Headquarters location

Austell, GA, US

Year founded

2009

Social media

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