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Computer Systems Validation Jobs (NOW HIRING)

Catalent

Computer Systems Engineer

Kansas City, MO · On-site

Responsibilities : • Works within the Biologics Validation team in the enhancement of existing computer system validation programs for the validation of new and existing laboratory computer systems ...

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How much do computer systems validation jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for computer systems 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 work of computer system validation?

Computer Systems Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of computer system validation?

The salary for a Computer Systems Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Entry-level roles may start lower, while experienced professionals with regulatory knowledge can earn higher salaries in the pharmaceutical, biotech, or medical device industries.

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

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries such as pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements like FDA or EMA guidelines, making it a stable and in-demand career path for those with technical and regulatory knowledge.

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

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

Is CSV a skill?

In the context of Computer Systems Validation, CSV is not a skill but an abbreviation for Computer System Validation, which involves verifying that computer systems meet regulatory requirements. Skills relevant to CSV include knowledge of validation protocols, regulatory standards like GxP, and proficiency with validation tools and documentation. Understanding these concepts is essential for professionals working in regulated industries such as pharmaceuticals and biotech.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
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Computer Systems Validation jobs near you
Infographic showing various Computer Systems Validation job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 79% Full Time, 13% Part Time, and 7% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation (Analytical Equipment), Specialist IV

Lonza

Portsmouth, NH • On-site

Full-time

Retirement

Posted 8 days ago

Lonza rating

8.1

Company rating: 8.1 out of 10

Based on 40 frontline employees who took The Breakroom Quiz

31st of 71 rated pharmaceutical

Job description

Computer Systems Validation (Analytical Equipment), Specialist IV
Location: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Analytical Equipment Validation (AEV) Specialist, Level 4 provides team leadership and training to assess new and changing analytical computer systems to ensure compliance with company policies, procedures and industry guidance. Assess risk and implement a risk based approach to categorize computerized systems, change requests from a Validation standpoint and support completion of validation activities for new and existing systems. The AEV Specialist role will support end to end validation lifecycle, from initiation to decommissioning of analytical systems, and collaborate with both internal and external customers. Be involved as the Analytical Computer System Subject Matter Expert (SME), during small and large-scale projects.
What you will get:
  • A collaborative and inclusive work environment.
  • Opportunities for career growth and development.
  • Access to cutting-edge technologies and tools.
  • Competitive compensation and benefits package.
  • 401(k) matching plan.
  • Supportive leadership and mentoring.
  • Commitment to ethical and sustainable practices.

Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
  • Lead end-to-end validation for analytical equipment as a Subject Matter Expert (SME), ensuring strict adherence to cGMP and quality standards.
  • Manage Computer System Validation (CSV) and Data Integrity (DI) assessments for all system changes and existing computerized platforms.
  • Execute validation maintenance through periodic reviews and the authorship of Validation Plans, Reports, and Master Plans.
  • Review and approve technical protocols, including IQ/OQ/PQ and TrackWise quality records, to ensure compliance.
  • Conduct specialized risk assessments, including ERES, Data Integrity Risk Assessments (DIRA), and Audit Trail Risk Assessments (ATRA).
  • Drive gap remediation by identifying process deficiencies and managing Deviations and Corrective and Preventive Actions (CAPA).
  • Provide cross-functional leadership by mentoring junior specialists and collaborating with teams to ensure on-time closure of quality records.

What we are looking for:
  • Bachelor's degree in computer science, engineering, or related field.
  • At least 5+ years of experience in computer systems validation.
  • 5+ years of Experience in working in a cGMP facility.
  • Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer
    Systems Validation. ( especially for analytical computerized systems).
  • Works independently and in teams.
  • Background in biotech, pharma, or medical device industry.
  • Ability to work independently and on-site in Portsmouth NH.

About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values-Collaboration, Accountability, Excellence, Passion, and Integrity-reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.

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