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Validation Senior Specialist - Computer Systems Jubilant HollisterStier Spokane is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ...

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Computer Systems Validation Specialist information

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

As of Sep 11, 2026, the average hourly pay for computer systems 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 is a computer systems validation specialist?

Computer Systems Validation Specialists are professionals responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or medical devices, meet all required standards for quality, compliance, and functionality. They develop and execute validation protocols, document testing procedures, and verify that systems consistently produce results that meet predetermined specifications. Their work is essential for meeting regulatory guidelines such as those set by the FDA, EMA, or other governing bodies, helping organizations avoid costly compliance issues and ensuring patient safety.

What are the key skills and qualifications needed to thrive as a computer systems validation specialist?

To thrive as a Computer Systems Validation Specialist, you need a solid background in computer science, information technology, or a related field, often supported by a relevant degree and experience with regulatory compliance in industries like pharmaceuticals or healthcare. Familiarity with validation tools, documentation management systems, and regulations such as FDA 21 CFR Part 11 or GAMP 5 is typically required, and certifications like CSV Professional (CSV-P) can be advantageous. Strong attention to detail, problem-solving abilities, and effective communication are crucial soft skills for ensuring thorough validation and collaboration with cross-functional teams. These skills and qualifications are vital to ensure that computer systems meet regulatory standards, maintain data integrity, and support quality assurance in regulated environments.

What are some common challenges faced by computer systems validation specialists when working with cross-functional teams?

Computer Systems Validation Specialists often collaborate with IT, Quality Assurance, and end-users to ensure systems meet regulatory requirements. A common challenge is aligning the diverse expectations and communication styles among these groups, especially when interpreting compliance standards. Specialists must facilitate clear documentation, manage timelines, and address technical misunderstandings, all while ensuring validation deliverables are met. Building strong working relationships and proactively addressing issues helps streamline project progress and maintain compliance.

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

AspectComputer Systems 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
Primary FocusValidating computer systems to ensure complianceEnsuring product and process quality
Common UsageRegulatory compliance, validation projectsProcess improvement, defect prevention

While both roles aim to ensure quality and compliance, the Computer Systems Validation Specialist primarily focuses on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. The Quality Assurance Specialist has a broader scope, overseeing overall product and process quality across various sectors. Both roles require similar certifications and work in regulated environments, but their core responsibilities differ in scope and focus.

Who are the top companies hiring for Computer Systems Validation Specialist jobs?

The top employers for Computer Systems Validation Specialist jobs are:

What states have the most Computer Systems Validation Specialist jobs?

States with the most job openings for Computer Systems Validation Specialist jobs include:

What are popular job titles related to Computer Systems Validation Specialist jobs?

For Computer Systems Validation Specialist jobs, the most frequently searched job titles are:

Computer Systems Validation Specialist jobs near you
Infographic showing various Computer Systems Validation Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 9% Part Time, 4% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Specialist III

Portsmouth, NH • On-site

Lonza
Biotechnology Research and Development • 10K+ employees
Learn more about Lonzaexternal

Full-time

Retirement

Re-posted 16 days ago

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

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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About Lonza

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Industry

Biotechnology research and development and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Bern, KS, US

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