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Computer Systems Validation Jobs (NOW HIRING)

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Rockville, MD

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

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Computer Systems Validation information

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How much do computer systems validation jobs pay per hour?

As of Jul 1, 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 a CSV engineer?

A Computer Systems Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications in validation or quality assurance and proficiency with regulatory standards like FDA or GxP can influence compensation levels.

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 like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements such as FDA or EMA guidelines. The field offers steady employment opportunities, especially for professionals with certifications like GAMP or 21 CFR Part 11 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.

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 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. Professionals in this role often have skills in hardware description languages and verification tools such as SystemVerilog and UVM.

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 41% Full Time, and 59% Part Time. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer Systems Validation Specialist III

Computer Systems Validation Specialist III

Lonza

Dover, NH • On-site

Other

Retirement

Posted 22 hours ago

Lonza rating

8.2

Company rating: 8.2 out of 10

Based on 41 frontline employees who took The Breakroom Quiz

29th of 73 rated pharmaceutical

Job description

Computer Systems Validation Specialist III

Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.

The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.

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.

Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

  • Perform all aspects of QMS process’ – Change Control, Deviations,

  • CAPAs.

  • Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects.

  • Author/Review/Approve all end to end Computer system validation life-

  • cycle deliverables/activities.

  • Schedule qualification activities and personnel to meet business,

  • manufacturing, engineering and quality objectives.

  • Revise and maintain SOPs to ensure continuous improvement and

  • compliance to GROUP/CORP procedures.

  • Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.).

  • Support Validation requests as a CSV SME, during Customer audits and inspections.

What we are looking for:

  • Bachelor’s degree in computer science, engineering, or related field.

  • At least 3+ years of experience in computer systems validation.

  • 3+ 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 of 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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