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Computer Systems Validation Jobs (NOW HIRING)

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

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 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 Engineer

CAI

Rockville, MD • On-site

$75K - $106K/yr

Full-time

Medical, Life, PTO

Posted 19 days ago

Job description

Are You Ready?
CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.
Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there.
Our Foundational Principles:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
We work diligently to accomplish team goals and live our core values:
- Team Before Self
- Respect for Others
- Can-Do Attitude
This position could report to Rockville, MD or Frederick, MD
Key Responsibilities
Documentation & Compliance
Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
Generate and execute test protocols and scripts
Ensure adherence to 21 CFR Part 11 and data integrity principles
Review and contribute to validation plans and risk assessments
System & Industry Expertise
Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
Utilize familiarity with S88/S95 batch control standards
Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
Client Support & Technical Execution
Support client engagements with strong customer-service orientation
Perform system assessments and remediation related to data integrity
Collaborate with client teams to ensure validation compliance and delivery
Qualifications and Experience
Bachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
Minimum of 3+ years of experience in 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)
Familiarity with S88/S95 batch control standards
Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
Experience with multiple automation and manufacturing execution systems is highly desirable
Data integrity assessment/remediation experience is a plus
Other Requirements
- Excellent oral and written communication skills in English
- Ability to travel domestically and internationally as required
- Willingness to work paid overtime when needed
- Must be authorized to work in the U.S. without current or future sponsorship
Critical Competencies
Influence Strategy
- Pursues opportunities based on organizational fit and strategy
- Identifies high-impact, innovative solutions
Satisfy the Customer
- Anticipates and meets client needs
- Delivers high-quality solutions and maintains satisfaction
Plan for Success
- Aligns business goals with execution plans
- Allocates resources and builds risk mitigation strategies
Pursue Execution
- Prioritizes effectively and ensures accountability
- Proactively addresses challenges
Tailor Communication
- Communicates clearly and professionally
- Adapts style for technical and non-technical audiences
Build Partnerships
- Builds cross-functional networks
- Promotes collaboration and stakeholder engagement
Influence Others
- Gains support through sound reasoning
- Promotes innovation and value
Develop Self and Others
- Demonstrates integrity and commitment to growth
- Builds effective relationships internally and externally
#LI-MV1
$75,000 - $106,000 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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