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Computer Systems Validation Specialist Jobs (NOW HIRING)

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 ...

CAI

Computer Systems Validation Engineer

Boston, MA · 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

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 ...

Care Access

Computer Systems Validation Engineer

$80K - $120K/yr

How This Role Makes a Difference The Computer System Validation Engineer is responsible for ensuring that computerized systems used across the organization are validated, maintained, and compliant ...

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

Boston, MA

$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 ...

Care Access

Computer Systems Validation Engineer

OR · On-site +1

$80K - $120K/yr

How This Role Makes a Difference The Computer System Validation Engineer is responsible for ensuring that computerized systems used across the organization are validated, maintained, and compliant ...

Curia, Inc.

Validation Specialist III

Albuquerque, NM · On-site

Validation Specialist III in Albuquerque, NM Build your future at Curia, where our work has the ... system, and computer system validations in accordance with cGMP, FDA regulations, and industry ...

CAI

Computer Systems Validation Engineer

Baltimore, 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 ...

AMRI

Validation Specialist III

Albuquerque, NM · On-site

Validation Specialist III in Albuquerque, NM Build your future at Curia, where our work has the ... system, and computer system validations in accordance with cGMP, FDA regulations, and industry ...

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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 13, 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 Engineer

Rockville, MD

CAI
See more jobs at CAIexternal

$75K - $106K/yr

Full-time

Medical, Life, PTO

Re-posted 8 days ago

Key responsibilities

  • Author GxP computer validation documentation such as URS, FRS, RTM, and summary reports.

  • Generate and execute test protocols and scripts to ensure system validation.

  • Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems.

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
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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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.