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Computer Validation Jobs (NOW HIRING)

Workforce Genetics

CSV Engineer

Baltimore, MD · On-site

Act as a subject matter expert on computer validation lifecycle processes, articulating these to clients and regulatory bodies * Validate and qualify computerized manufacturing PLC-based and Windows ...

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How much do computer validation jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for computer validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

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. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

How to become a validation specialist?

To become a validation specialist, typically one needs a bachelor's degree in life sciences, engineering, or a related field, along with experience in quality assurance or manufacturing. Certification in validation or Good Manufacturing Practices (GMP) can enhance job prospects. Skills in documentation, attention to detail, and knowledge of validation tools and protocols are essential for success in this role.

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

AspectComputer ValidationQuality Assurance Specialist
Required CredentialsGxP, 21 CFR Part 11, validation certificationsISO standards, QA certifications, GxP knowledge
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, healthcare, regulated industries
Employer & Industry UsageRegulated industries requiring validated systemsEnsuring quality compliance across processes

Computer Validation focuses on verifying that computer systems meet regulatory requirements and function correctly, primarily in regulated industries. Quality Assurance Specialists oversee overall quality processes, ensuring compliance and standards across various operations. While both roles require knowledge of GxP and industry regulations, Computer Validation is more technical and system-specific, whereas QA Specialists have a broader scope in quality management.

What is the salary of a CSV engineer?

A CSV (Computer System Validation) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications. Senior roles or those with specialized skills in validation tools and regulatory compliance may earn higher salaries.

Is computer system validation a good field?

Computer validation professionals ensure that computer systems in regulated industries meet quality and compliance standards, often requiring knowledge of GxP regulations and validation tools. The field offers steady demand, especially in pharmaceuticals and biotech, with opportunities for certification and career growth. It is suitable for those with technical skills and attention to detail interested in quality assurance and regulatory compliance.
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Computer Validation jobs near you
Infographic showing various Computer Validation job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer Systems Validation Specialist

Computer Systems Validation Specialist

kindeva

Saint Louis, MO • On-site

Other

Re-posted 29 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated, maintained, and compliant with applicable regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

This role supports the full lifecycle of computerized systems including implementation, qualification, maintenance, periodic review, and retirement, ensuring data integrity, system reliability, and inspection readiness across multiple sites or facilities.

Responsibilities

  • Validation Lifecycle Execution
    • Lead and/or support validation activities for GxP computerized systems including MES, SCADA/PLC, LIMS, EM systems, and serialization/packaging systems
    • Author and execute validation documentation: URS, FS/DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Periodic Reviews / Audit Trail Reviews
    • Ensure validation deliverables meet internal SOPs and regulatory expectation
  • Regulatory Compliance & Data Integrity
    • Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
    • Perform periodic reviews of validated systems
    • Support FDA, EMA, and internal audits/inspections
    • Assess and remediate data integrity risks
  • Change Control & Lifecycle Management
    • Support system changes through formal change control processes
    • Evaluate impact of updates, patches, and configuration changes
    • Ensure appropriate re-validation activities
    • Maintain systems in a validated state
  • Risk-Based Validation Strategy
    • Apply GAMP 5 risk-based validation approach
    • Classify systems based on complexity and GxP impact
    • Lead risk assessments (FMEA, system risk ranking)
  • Cross-Functional Collaboration
    • Partner with IT, QA, Manufacturing, MS&T, and Engineering
    • Provide CSV guidance during system implementation and facility startup
    • Support digital transformation initiatives
  • Documentation & Inspection Readiness
    • Maintain GMP-compliant validation documentation
    • Ensure audit readiness and traceability
    • Support responses to audit findings and regulatory observations
  • Continuous Improvement
    • Improve validation processes and templates
    • Support implementation of electronic validation systems (e.g., Kneat, Veeva)
    • Drive standardization across sites

Qualifications

  • Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field
  • Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech environments
  • Experience with manufacturing and laboratory systems validation
  • Hands-on experience with Part 11 / Annex 11 compliance
  • Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+
  • Familiarity with MES, ERP, LIMS, SCADA/PLC systems
  • Understanding of system architecture, interfaces, backup, disaster recovery, and cybersecurity
  • Experience in aseptic/sterile injectable manufacturing preferred
  • Multi-site validation program experience preferred
  • Familiarity with serialization, AVI systems, and cold storage monitoring preferred
  • Experience with Kneat, ValGenesis, or Veeva is desirable
  • Experience with facility startup and commissioning

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