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Computer System Validation Csv Pharmaceutical Jobs

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... computer system validation and information technology consulting services to pharmaceutical ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... computer system validation and information technology consulting services to pharmaceutical ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Moriah Engineering

PR · On-site

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 ... the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and ...

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

As of Jun 9, 2026, the average hourly pay for computer system validation csv pharmaceutical 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 difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are some common challenges faced by Computer System Validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional in the pharmaceutical industry, and why are they important?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is Computer System Validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
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Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 1% Internship, 22% Full Time, 64% Part Time, 10% Contract, and 2% Nights. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Specialist

kindeva

Saint Louis, MO

Other

Posted 24 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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