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Computer Systems Validation Jobs in Massachusetts

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 ...

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 ...

Syner-G

Validation Engineer

Waltham, MA · On-site +1

Perform P&ID walkdowns to verify installation and system readiness. * Conduct thermal mapping of ... While performing the duties of this job, the employee is regularly required to use a computer ...

Moderna

Principal System Engineer LIMS

Norwood, MA · On-site

... computer systems validation practices (GAMP) • Strong communication skills (verbal and written) • Demonstrated ability to work independently and collaboratively on cross-functional teams • ...

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

Support equipment, utility, facility, process, cleaning, and computerized system validation ... Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range: $33.00 ...

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Computer Systems Validation information

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$11

$59

$93

How much do computer systems validation jobs pay per hour?

As of Aug 18, 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 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 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 are some common challenges faced in a computer systems validation 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 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 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 August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 7% Part Time, 3% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $123,391 per year, or $59.3 per hour.

Sr. CSV Validation Engineer

Genezen

Lexington, MA

$115K - $140K/yr

Full-time

Re-posted 27 days ago

Job description

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.

ESSENTIAL JOB FUNCTIONS

  • Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
  • Review and approve qualification documentation on behalf of the validation function
  • Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standards
  • Support investigations into protocol nonconformances and site deviations
  • Serve as initiator and owner of validation related change controls and corrective and preventative actions
  • Author standard operating procedures related to CSV validation practices
  • Support the execution and generation of formal risk assessments
  • Enhance CSV validation programs
  • Analyze validation data, identify gaps, and support investigations and corrective actions
  • Represent CSV during audits and regulatory inspections

SPECIAL WORK REQUIREMENTS

  • Fully onsite position
  • Strong communication skills
  • Familiarity with Microsoft Office, Excel, and Visio
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities
  • The ability to communicate with fellow project team members
  • Criminal background check required
  • Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

A minimum of a Bachelor's degree in Engineering, Computer
Science or related discipline

Desired

ON-THE-JOB EXPERIENCE

7+ years of 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 experience levels from Genezen and other contract firms

Essential

The ability to report on project activity in a clear and concise manner

Essential

The ability to communicate with fellow project team members

Essential

Understanding of cGMP regulations

Essential

Technical writing ability

Essential

Familiarity with Microsoft Office

Essential

Ability to work well with diverse groups in a matrix-style, growing, safety focused organization

Essential

Ability to manage multiple activities with challenging timelines

Essential

In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system

Essential

Pay Range:
The annual salary range for this position based upon level hired is: $115,000 - $140,000

Work Environment

  • Regularly sit for extended periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Rarely lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

  • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.