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Computer System Validation Jobs in Silver Spring, MD

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

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Computer System Validation information

See Silver Spring, MD salary details

$10

$55

$88

How much do computer system validation jobs pay per hour?

As of Jun 1, 2026, the average hourly pay for computer system validation in Silver Spring, MD is $55.98, according to ZipRecruiter salary data. Most workers in this role earn between $43.12 and $66.39 per hour, depending on experience, location, and employer.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
What are the most commonly searched types of Computer System Validation jobs in Silver Spring, MD? The most popular types of Computer System Validation jobs in Silver Spring, MD are:
What are popular job titles related to Computer System Validation jobs in Silver Spring, MD? For Computer System Validation jobs in Silver Spring, MD, the most frequently searched job titles are:
What job categories do people searching Computer System Validation jobs in Silver Spring, MD look for? The top searched job categories for Computer System Validation jobs in Silver Spring, MD are:
What cities near Silver Spring, MD are hiring for Computer System Validation jobs? Cities near Silver Spring, MD with the most Computer System Validation job openings:
Computer Systems Validation Lead

Computer Systems Validation Lead

Quality Agents, LLC

Rockville, MD

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 hours ago


Job description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries.


Our Computer Systems Validation Leads work directly with our clients to support activities that include, but are not limited to, documentation review and approval, including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports. The individual will contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. Responsibilities include:


  • Optimization of CQV support process, including developing including developing standards and KPI reports.
  • Compile and analyze validation data and make recommendations for changes and/or improvements
  • Maintain all documentation pertaining to computer systems validation
  • Data integrity qualification
  • Participate in cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups
  • Some travel is required


Skill level & requirements:


  • Experience with IQ, OQ, PQ Final reports relating to Computer Systems Validation.
  • Experience writing validation master plans.
  • Experience with Configuration, design, data and traceability matrices.
  • Validation experience with automated systems is preferred
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11
  • Strong knowledge of computerized system development life cycle approach is required
  • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
  • Experience coordinating Quality documentation, specifically qualification/Validation documentation
  • Demonstrated excellent leadership/Project Manager skills
  • Strong technical writing skills
  • Excellent written and verbal communication skills
  • The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required


Minimum Requirements:


  • Bachelor's degree in a technical discipline (i.e. Engineering, Chemistry, Microbiology, Biology)
  • 3 - 5 years Computer Systems Validation background
  • 3 - 5 years IT Quality Assurance / Validation experience
  • Current driver's license and auto insurance or other means of independent transportation


Quality Agents offers a full suite of benefits for full-time employees including:


  • Health, dental and vision insurance
  • Life, AD&D and Disability Insurance
  • Health savings account for participants in our health plan
  • 401k retirement plan
  • Paid time off
  • Paid holidays


Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application.After that time, or if your application information changes, please submit your application again.