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Computer System Validation Csv Jobs in Massachusetts

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 ...

TEKsystems

Senior Business Analyst

Lexington, MA

$60 - $75/hr

Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, including: * User Requirements Specifications (URS) * Risk Assessments * Traceability Matrices * Test ...

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 ...

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Computer System Validation Csv information

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How much do computer system validation csv jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for computer system validation csv in Massachusetts is $56.57, according to ZipRecruiter salary data. Most workers in this role earn between $42.55 and $70.34 per hour, depending on experience, location, and employer.

What is a computer system validation CSV?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are the key skills and qualifications needed to thrive in computer system validation CSV?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What are some typical challenges faced by computer system validation CSV professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

Is computer system validation a good field?

Computer System Validation (CSV) is a specialized field within regulated industries like pharmaceuticals and biotech, focusing on ensuring software and systems meet compliance standards such as GxP. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or 21 CFR Part 11 knowledge. The field provides stable employment with growth potential, especially as compliance regulations become more stringent.

What are the most commonly searched types of Computer System Validation Csv jobs in Massachusetts?

The most popular types of Computer System Validation Csv jobs in Massachusetts are:

What are popular job titles related to Computer System Validation Csv jobs in Massachusetts?

For Computer System Validation Csv jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv jobs in Massachusetts look for?

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Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $117,673 per year, or $56.6 per hour.

CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, MA • On-site

Other

Posted 6 days ago

Job description

Job Summary:
  • We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
  • The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance.

Roles & Responsibilities:
  • Develop, execute, and maintain Computer System Validation (CSV) documentation and validation protocols for QC laboratory systems and manufacturing systems.
  • Support the complete validation lifecycle, including preparation, execution, review, and approval of User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessments, and Validation Reports.
  • Perform risk assessments to identify and mitigate validation and compliance risks.
  • Ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal quality standards.
  • Review validation documentation to ensure accuracy, completeness, and regulatory compliance.
  • Collaborate with Quality Assurance (QA), Manufacturing, Engineering, and IT teams to support validation activities and system implementations.
  • Provide validation support for QC laboratory systems and manufacturing equipment throughout their lifecycle.
  • Assist with change control, deviation investigations, and periodic reviews related to validated systems.
  • Maintain accurate validation records and ensure documentation is audit ready.
  • Support internal and external regulatory inspections by providing validation documentation and technical expertise.

Requirements / Qualifications:
  • Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field.
  • Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
  • Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations.
  • Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation.
  • Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports.
  • Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams.
  • Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices.
  • Excellent technical writing, documentation, communication, and problem-solving skills.
  • Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements.

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