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Csv Validation Engineer Jobs (NOW HIRING)

Validation Engineer Location: Boston, MA Overview This engagement supports a large-scale Quality ... CSV / Part 11 exposure * Experience with high-volume documentation remediation Thanks & Regards ...

Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...

Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...

Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...

Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...

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Support Computerized System Validation (CSV) activities * Assist in validation of autoclaves, CIP ... Collaborate with Quality, Manufacturing, and Engineering teams to resolve validation issues

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Csv Validation Engineer information

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How much do csv validation engineer jobs pay per hour?

As of Jun 7, 2026, the average hourly pay for csv validation engineer in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CSV Validation Engineer, and why are they important?

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What are Csv Validation Engineers?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV Validation Engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

More about Csv Validation Engineer jobs
What cities are hiring for Csv Validation Engineer jobs? Cities with the most Csv Validation Engineer job openings:
What states have the most Csv Validation Engineer jobs? States with the most job openings for Csv Validation Engineer jobs include:
Infographic showing various Csv Validation Engineer job openings in the United States as of May 2026, with employment types broken down into 94% Full Time, 3% Part Time, and 3% Contract. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Validation Engineer/CSV Engineer

Contractor

Posted 17 days ago


Job description

Company Description
  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description

Responsibilities:

  • Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
  • Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
  • Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
  • Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
  • Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
  • Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
  • Traceability Matrix.
  • Periodic Reviews.
  • System Retirement/Decommissioning.
  • Execution of Dry/Test protocol run.
  • Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
  • Perform System Retirement/Decommissioning of systems not in business.
  • Work closely with software development and IT teams to establish best practices for quality and compliance.
  • Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
  • Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements:

  • A Minimum bachelor's degree in engineering, Science or related technical field.
  • Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
  • Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Experience with non-product software validation, including tools for development, testing, and maintenance.
  • Good knowledge and experience of CSV activities but not limited to.
  • GxP and 21 CFR Part 11 applicability/criticality assessment.
  • Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
  • Execution of Dry/Test protocols.
  • Conduct Periodic Reviews of systems.
  • Perform System Retirement of systems that are not in business.
  • Understanding of Medical Device Quality and Compliance.
  • Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
  • Working experience in Product Lifecycle Management (PLM) tool.
  • Sound knowledge of computer system development lifecycles.
  • Knowledge of JIRA, JAMA software and test automation is a plus.
Additional Information

All your information will be kept confidential according to EEO guidelines.


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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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