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Computer Systems Validation Jobs (NOW HIRING)

CAI

Computer Systems Validation Engineer

Baltimore, 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

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 ...

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How much do computer systems validation jobs pay per hour?

As of Aug 10, 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 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.

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 are some common challenges faced in a computer systems validation 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 August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 9% Part Time, 4% Contract, and 1% Nights. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Specialist

Lonza

Portsmouth, NH • On-site

Full-time

Re-posted 2 days ago

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical

Job description

Computer Systems Validation (CSV) Specialist
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Computer Systems Validation (CSV) Specialist 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.
  • 3+ years experience in Computer Systems Validation and in a cGMP facility.
  • 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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