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Computer System Validation Manager Jobs in Gaithersburg, MD

CAI

Computer Systems Validation Engineer

Rockville, MD

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

ECS

Senior Computer System Analyst

Falls Church, VA · On-site

Everforth ECS is seeking a Senior Computer System Analyst to work in Falls Church, VA . This ... Experience with OCONUS / Global Program Management and with DoD IT systems maintenance and ...

MSD

Manager I, Validation

Rockville, MD · On-site

$101.40K - $154.65K/yr

Provide subject matter expertise for new equipment, systems, product introductions, and facility expansions. * Manage validation and calibration schedules to ensure timely execution. * Oversee ...

Meso Scale Discovery

Manager I, Validation

Rockville, MD

$101.40K - $154.65K/yr

Provide subject matter expertise for new equipment, systems, product introductions, and facility expansions. * Manage validation and calibration schedules to ensure timely execution. * Oversee ...

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Computer System Validation Manager information

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$51.3K

$113.9K

$173.4K

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

As of Jun 1, 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 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 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 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:
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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
Computer Systems Validation Lead

Computer Systems Validation Lead

Quality Agents, LLC

Rockville, MD

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 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.

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