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Computer System Validation Csv Jobs (NOW HIRING)

PSC Biotech

LabWare Specialist

Ventura, CA · On-site

Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. * Author and/or contribute to validation deliverables. * Ensure full ...

RESILIENCE

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

New

PSC Biotech

CA

Validation & CSV Support Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. Author and/or contribute to validation deliverables. Ensure full ...

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

Amzur Technologies, Inc.

CSV Lead

Princeton, NJ · On-site

Experience in the pharmaceutical, biotechnology, or medical device industry * 10+ years of experience in Computer System Validation (CSV) * Experience in FDA and/or global regulated environments with ...

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

As of Jun 26, 2026, the average hourly pay for computer system validation csv in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?

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 is a Computer System Validation (CSV) job?

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 some typical challenges faced by Computer System Validation 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.

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Computer System Validation CSV jobs near you
Infographic showing various Computer System Validation Csv job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Senior Quality Validation & Compliance Manager

IT Minds LLC

San Diego, CA • On-site

Other

Posted 10 days ago

Job description

Job Title: Senior Quality Validation & Compliance Manager

Location: Remote / Hybrid / Onsite

Duration: Long-Term Contract

Position Overview

We are seeking a highly experienced Senior Quality Validation & Compliance Manager to lead Quality Systems, Validation, Computer System Validation (CSV), Regulatory Compliance, and GxP initiatives within regulated Pharmaceutical, Biotechnology, Medical Device, and Life Sciences environments.

The ideal candidate will possess extensive experience managing Quality Management Systems (QMS), validation programs, regulatory inspections, audit readiness, data integrity initiatives, and compliance activities while ensuring adherence to FDA, EMA, MHRA, ICH, GAMP 5, and global GxP requirements.

This role will serve as a key quality leader supporting Quality Assurance, Validation, Regulatory Affairs, Manufacturing, Engineering, Laboratory Operations, and IT organizations.

Key Responsibilities

  • Lead and maintain enterprise Quality Management Systems (QMS) programs.
  • Provide oversight of Validation Lifecycle Management activities including Process Validation, Equipment Qualification, Cleaning Validation, Analytical Method Validation, and Computer System Validation (CSV).
  • Develop, review, and approve validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, Validation Reports, SOPs, and Quality Records.
  • Ensure compliance with GMP, GLP, Google Cloud Platform, GVP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, and global regulatory requirements.
  • Lead quality investigations, deviations, CAPAs, change controls, non-conformances, and remediation activities.
  • Support FDA, EMA, MHRA, ISO, and customer inspections and audits.
  • Drive inspection readiness programs and regulatory compliance initiatives.
  • Partner with cross-functional teams including Quality Assurance, Regulatory Affairs, Validation, Manufacturing, Engineering, Laboratory Operations, and IT.
  • Conduct risk assessments and implement risk-based validation approaches.
  • Lead continuous improvement initiatives to strengthen quality and compliance processes.
  • Mentor and provide leadership to quality, validation, and compliance teams.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or related field.
  • 10+ years of Quality Assurance, Validation, Compliance, or Regulatory experience within Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.
  • 5+ years of leadership experience managing Quality, Validation, or Compliance programs.
  • Strong experience supporting regulated GxP environments.

Mandatory Experience

  • Quality Management Systems (QMS)
  • Computer System Validation (CSV)
  • Process Validation
  • Equipment Qualification (IQ/OQ/PQ)
  • GMP / cGMP Compliance
  • GxP Compliance (GMP, GLP, Google Cloud Platform)
  • CAPA Management
  • Deviation Investigations
  • Change Control
  • Risk Assessments
  • Audit Management
  • Inspection Readiness
  • Regulatory Compliance
  • Data Integrity (ALCOA+)
  • Validation Lifecycle Management

Regulatory & Compliance Expertise

Strong knowledge of:

  • FDA Regulations
  • 21 CFR Part 11
  • 21 CFR Parts 210, 211, and 820
  • EU Annex 11
  • GAMP 5
  • ICH Guidelines
  • ISO 13485
  • Data Integrity Requirements
  • ALCOA+ Principles
  • GMP, GLP, Google Cloud Platform, and GxP Regulations

Preferred Systems Experience

Experience supporting and validating one or more of the following systems:

  • TrackWise
  • Veeva
  • LabWare LIMS
  • Empower
  • SAP
  • MasterControl
  • ETQ
  • ComplianceWire
  • DeltaV
  • MES
  • SCADA
  • Quality Management Platforms

Preferred Industry Experience

  • Pharmaceutical Manufacturing
  • Biotechnology
  • Biologics
  • Cell & Gene Therapy
  • Medical Devices
  • Combination Products
  • Laboratory Informatics
  • Global Quality & Compliance Programs

Preferred Certifications

  • ASQ Certified Quality Engineer (CQE)
  • ASQ Certified Quality Auditor (CQA)
  • PMP Certification
  • Lean Six Sigma Green Belt or Black Belt
  • ISO Lead Auditor Certification

Top Mandatory Skills

Quality Assurance | QMS | CSV | Validation | GxP | GMP | Regulatory Compliance | CAPA | Deviations | Change Control | Audit Readiness | Data Integrity | Risk Assessments | IQ/OQ/PQ | FDA Compliance | GAMP 5

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |

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