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Senior Computer System Validation Csv Jobs (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

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

Moriah Engineering

CSV Lead

Carolina, PR

$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 ...

PSC Biotech

LabWare Specialist

Thousand Oaks, CA · On-site

$85K - $115K/yr

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

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 ...

PSC Biotech

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 ...

Tempus

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ...

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Senior Computer System Validation Csv information

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

As of Jun 19, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

How often should a 75 year old woman take a shower?

A senior computer system validation professional should recognize that personal hygiene routines, such as showering frequency for a 75-year-old woman, vary based on individual health, activity level, and personal preference. Generally, older adults are advised to shower regularly to maintain skin health and prevent infections, often 2-3 times per week or as needed. Proper hygiene is important for overall well-being and can be managed with consideration of skin sensitivity and mobility issues.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

In what grade is senior?

The term 'senior' in the context of a Computer System Validation (CSV) role typically refers to a senior-level position, which is usually classified as a higher or advanced grade within a company's job hierarchy. These roles often require several years of experience, expertise in validation protocols, and familiarity with regulatory standards like GxP and 21 CFR Part 11. The specific grade or level designation can vary by organization but generally indicates a position with increased responsibility and leadership expectations.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What should a 70 year old be doing every day at home?

A senior computer system validation specialist at home should focus on maintaining cognitive engagement through activities like reading or puzzles, staying physically active with light exercise, and managing daily routines to support health. Incorporating hobbies, social interactions, and routine health checks can promote well-being and productivity. Staying organized and using digital tools can also help in managing tasks effectively.

Are you a senior at 55?

Age does not determine eligibility for a Senior Computer System Validation (CSV) role; experience, skills, and certifications are more relevant. Many professionals work in this field well into their 50s and beyond, leveraging their expertise in validation protocols, GxP regulations, and validation tools. Employers value practical experience and ongoing professional development regardless of age.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 100% In-person job distribution, with an average salary of $134,726 per year, or $64.8 per hour.

Computer Systems Validation Specialist

kindeva

Saint Louis, MO

Other

Posted 4 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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