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Computer System Validation Manager Jobs in Gaithersburg, MD

Lonza

Director, Automation

Walkersville, MD · On-site +1

$203K - $237K/yr

Provide leadership for automation-related commissioning, qualification, computer system validation (CSV), and start-up readiness activities * Manage automation vendors, system integrators, and ...

Lonza

Director, Automation

Walkersville, MD · On-site +1

$203K - $237K/yr

Provide leadership for automation-related commissioning, qualification, computer system validation (CSV), and start-up readiness activities * Manage automation vendors, system integrators, and ...

Valspec

CSV Lead

Rockville, MD

$104K - $137K/yr

... CSV (Computer System Validation) Lead to support automation and digital systems validation on a major greenfield pharmaceutical manufacturing program. What You'll Do * Manage CSV execution and ...

Guidehouse

Computer Systems Analyst

Rockville, MD · On-site

$98K - $163K/yr

The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... management levels, technical dependencies, timeline impact and risks Employment Benefits:

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD · On-site

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... management levels, technical dependencies, timeline impact and risks Employment Benefits:

Guidehouse

Computer Systems Analyst

Rockville, MD · On-site

$98K - $163K/yr

The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.

H. T. PROF Group

Systems Integration Engineer

Germantown, MD · On-site

$110K - $135K/yr

Bachelor's degree in Engineering (Systems, Electrical, Mechanical, Computer Engineering, or related ... Experience executing or supporting test procedures and system validation * Ability to interpret ...

US Legislative Branch

Computer Scientist

Washington, DC · On-site

$121K/yr

Additional qualification information can be found from the following Office of Personnel Management ... computer system architecture and system software organization, the representation and ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Gaithersburg, MD

Computer System Validation Manager information

See Gaithersburg, MD salary details

$51.3K

$113.9K

$173.4K

How much do computer system validation manager jobs pay per year?

As of Sep 10, 2026, the average yearly pay for computer system validation manager in Gaithersburg, MD is $113,896.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,500.00 and $142,600.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Gaithersburg, MD?

The most popular types of Computer System Validation jobs in Gaithersburg, MD are:

What are popular job titles related to Computer System Validation Manager jobs in Gaithersburg, MD?

For Computer System Validation Manager jobs in Gaithersburg, MD, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in Gaithersburg, MD look for?

The top searched job categories for Computer System Validation Manager jobs in Gaithersburg, MD are:

What cities near Gaithersburg, MD are hiring for Computer System Validation Manager jobs?

Cities near Gaithersburg, MD with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Gaithersburg, MD as of September 2026, with employment types broken down into 81% Full Time, 18% Part Time, and 1% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $113,896 per year, or $54.8 per hour.

Jr. Validation Engineer/QA Analyst/ Jr. QA Tester

Herndon, VA • On-site

IT EXCEL LLC
Software Development • 51 - 200 employees
Learn more about IT EXCEL LLCexternal

$55K - $58K/yr

Full-time

Re-posted 9 days ago

Job description

Company Description

I.T. EXCEL is an E-VERIFIED Company.

 

I.T. Excel is a new breed of service firm - an industry-focused consulting and integration firm offering a broad range of solution offerings to clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions company with over 250 employee .We help companies bring improved focus to IT and how it aligns with the business, executes on its priorities and balances between innovation and efficiency. We have successfully shared with many of our clients the strategies, approaches and techniques necessary to transform IT capability and enable the implementation of business strategy. We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation.

Job Description

Description: WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Training Location: Reston, VA


Minimum Experience: Recent college graduates with no experience or graduates with few years of experience preferred. Computer literate and familiar with the use of word processing, spreadsheet, and basic database applications preferred.
Skills/Abilities/Competencies Required:
Must be ambitious, have strong work ethic, and a willingness to learn
Be a fast learner with strong problem solving skills
Demonstrated strength in verbal and written communication
Positive & winning attitude
Candidate must be willing to relocate
Excellent communication and interpersonal skills
Ability to understand and effectively communicate at all management levels, technical dependencies, timeline impact and risks
Employment Benefits:
Competitive Base Salary: Base Pay of $55,000 - $58,000 / Yr with periodic reviews (usually every 6 months) and increments.

Qualifications

Qualifications: BS in Biomedical Engineering/ BS in Chemical Engineering/ Computer Science/ MS Computer Science/ BBA/ MBA/ Engineering degree required from an accredited university or college. 

Additional Information

All your information will be kept confidential according to EEO guidelines.

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