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Computer System Validation Specialist Jobs (NOW HIRING)

Validation Specialist Job Number: 26-00778 Be part of a company that delivers life-changing health ... This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems ...

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Computer System Validation Specialist information

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

As of Jun 9, 2026, the average hourly pay for computer system validation specialist 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 are the key skills and qualifications needed to thrive as a Computer System Validation Specialist, and why are they important?

To thrive as a Computer System Validation Specialist, you need expertise in computer science, regulatory compliance (such as FDA 21 CFR Part 11 and GxP), and a background in life sciences or IT, often supported by a relevant bachelor's degree. Familiarity with validation lifecycle documentation, risk management tools, and computerized system validation (CSV) software is essential. Strong analytical thinking, attention to detail, and effective communication skills help ensure thorough documentation and collaboration across departments. These abilities are crucial to maintain regulatory compliance, data integrity, and smooth system implementation in highly regulated industries.

What are some common challenges faced by Computer System Validation Specialists during project implementation?

Computer System Validation Specialists often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating with cross-functional teams like IT, QA, and business users. Navigating diverse documentation requirements and handling unexpected changes to system specifications can also be demanding. Effective communication, attention to detail, and proactive risk management are essential to successfully overcome these obstacles and deliver compliant, validated systems.

What Does a Computer System Validation Specialist Do?

A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality. As a CSV specialist, your responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. You also review test results and identify areas of improvement to implement changes. Other duties include providing technical expertise to customers and the validations department while communicating the validation plan and creating protocols. You may also ensure that each product is compliant with Current Good Manufacturing Practice (CGMP), Good Automated Manufacturing Practice (GAMP), and Code of Federal Regulations.

What does a Computer System Validation Specialist do?

A Computer System Validation Specialist ensures that computer systems used in regulated industries, such as pharmaceuticals or medical devices, comply with regulatory requirements and function as intended. They develop and execute validation protocols, document processes, and work closely with quality assurance and IT teams to maintain compliance. Their work helps guarantee data integrity, product quality, and patient safety by ensuring systems are reliable and audit-ready.

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

AspectComputer System Validation SpecialistQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, CSV-specific trainingISO 9001, Six Sigma, QA certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, software, healthcare sectors
Employer & Industry UsageRegulated industries requiring compliance documentationBroadly used across industries for process quality

The Computer System Validation Specialist focuses on ensuring computer systems meet regulatory standards through validation processes, primarily in regulated industries like pharma and biotech. In contrast, the Quality Assurance Specialist oversees overall quality processes, including audits and compliance, across various sectors. While both roles emphasize compliance and documentation, the CSV Specialist is more technical and specific to computer systems validation, whereas the QA Specialist has a broader scope in quality management.

What cities are hiring for Computer System Validation Specialist jobs? Cities with the most Computer System Validation Specialist job openings:
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What are popular job titles related to Computer System Validation Specialist jobs? For Computer System Validation Specialist jobs, the most frequently searched job titles are:
Infographic showing various Computer System Validation Specialist job openings in the United States as of May 2026, with employment types broken down into 5% As Needed, 40% Full Time, and 55% Part Time. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Specialist, Level 2

Lonza

Portsmouth, NH • On-site

Full-time

Posted 17 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

The Computer Systems Validation (CSV) Specialist, Level 2
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Computer Systems Validation (CSV) Specialist, Level 2 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members and will be involved as the QA CSV representative 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.
  • 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
  • Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.
  • Execute all responsibilities as CSV project lead for simple projects.
  • Oversee/perform all CSV qualification activities for DeltaV and Syncade systems.
  • Perform Validation Maintenance of computerized systems.
  • Review/Revise CSV SOPs.
  • Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc..)
  • Assist with audits and inspections.

What we are looking for
  • Bachelor's degree in computer science, engineering, or related field.
  • 0-4 years experience in Computer Systems Validation
  • 1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferred.
  • Experience leading projects and managing CAPAs and deviations.
  • Background in biotech, pharma, or medical device industry.
  • Strong attention to detail and ability to meet deadlines.
  • 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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