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Computer System Validation Manager Jobs in Maryland

Manage the medical image data automation, storage, and accessibility. * Assign, review and mentor ... Create system for generating reports to participants based on data collected in the field, by ...

Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit ...

Showing results 41-60

Computer System Validation Manager information

See Maryland salary details

$46.1K

$102.3K

$155.8K

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

As of Aug 12, 2026, the average yearly pay for computer system validation manager in Maryland is $102,310.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,300.00 and $128,100.00 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 Maryland? The most popular types of Computer System Validation jobs in Maryland are:
What are popular job titles related to Computer System Validation Manager jobs in Maryland? For Computer System Validation Manager jobs in Maryland, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Maryland look for? The top searched job categories for Computer System Validation Manager jobs in Maryland are:
What cities in Maryland are hiring for Computer System Validation Manager jobs? Cities in Maryland with the most Computer System Validation Manager job openings:
Infographic showing various Computer System Validation Manager job openings in Maryland as of August 2026, with employment types broken down into 71% Full Time, 15% Part Time, and 14% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution, with an average salary of $102,310 per year, or $49.2 per hour.

Computer Systems Analyst

Axle

Baltimore, MD

Full-time

Re-posted 25 days ago


Job description

(ID: 2026-2795)


Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).


Axle is seeking a Computer Systems Analyst to join our vibrant team at the National Institutes of Health (NIH) supporting the NIA in Baltimore, MD


Benefits We Offer:

  • 100% Medical, Dental & Vision Coverage for Employees
  • Paid Time Off and Paid Holidays
  • 401K match up to 5%
  • Educational Benefits for Career Growth
  • Employee Referral Bonus
  • Flexible Spending Accounts:
    • Healthcare (FSA)
    • Parking Reimbursement Account (PRK)
    • Dependent Care Assistant Program (DCAP)
    • Transportation Reimbursement Account (TRN)

Overview:

To serve as a Computer Systems analyst at NIA/IRP. Analyzing problems and propose solutions that enhance the operation of web-based data collection activities.

Requirements:

  • Provide expert recommendations in application of Perl CGI to other study investigators.

  • Make recommendations to physicians and technologists about optimal use of electronic media for record keeping and other study-related data management; Create medical image analysis evaluation portal for doctors.

  • Automate image transfer, storage, and conversion using DICOM, from multiple servers and medical imaging equipment, including but not limited to Hologic, Toshiba, GE; Manage the medical image data automation, storage, and accessibility.

  • Assign, review and mentor the computer support technician in the collection and removal of medical image data; Aid computer support technician in efforts to troubleshoot web application problems and server and network issues on the MRV.

  • Advise the clinical technicians on application use; Offer guidance on techniques to improve data collection; Ensure data integrity of information entered by technicians through communication and auditing.

  • Update Quest Diagnostics laboratory panels; Ensure successful lab data transfer, storage, and retrieval.

  • Coordinate account information for all staff.

  • Participate in weekly and monthly meetings regarding the overall status of the study, participant retention, and technical hurdles, ideas, and solutions.

  • Write reports and documentation related to programming tasks.

  • Ensure programs are clearly written, well documented, and can be supported and maintained by any programmer with an intermediate level of skill in the language using source code configuration and version management.

  • Coordinate full lifecycle of web-based applications.

  • Serve an expert resource by recommending, implementing, and maintaining best practices for programming on-line data collection and data review in a epidemiologic field study.

  • Serve as authoritative source for most effective and efficient web design that produces the most accurate data collection and data review -- this requires independent knowledge and skills in creating the most effective look and feel with the greatest logical flow for user interaction with the system.

  • Create novel solutions using best programming practices or revise existing computer code to reflect evolving standards using independent judgment about applying new methods only when they best serve the purposes of data collection.

  • Independently design and implement novel web-based data collection systems and programs for real-time medical examination data collection in the most appropriate programming language with minimal daily oversight.

  • Create novel participant and personnel management systems to meet study operational requirements such as tracking participants or scheduling participant visits, and implements and maintains programs and databases to perform this function.

  • Create system for generating reports to participants based on data collected in the field, by laboratory tests, by instruments, and by information entered into web-based forms.

  • Design, implement, and maintain databases that correspond to web-based programs, and implement programmatic mechanisms for transfers and backups from data collected in real-time on medical instruments such as EKG and DXA.

  • Design, implement, test, and deploy software that minimizes data entry by staff and makes maximum use of instrument interfaces without compromising functionality, availability, reliability, access, security, and performance of computing services for study staff and investigators.

  • Assign, review and mentor other programmers in development of applications to collect clinical research data and medical image data.

  • Perform database administration, database management, and database programming across multiple web-servers; Familiar with MySQL master-master replication.

  • Perform system administration of web-server systems to ensure ongoing operations without any failure of data entry.

  • Export data from relational database to other software such as statistical programs (e.g.,SAS) when needed by researchers and other programming personnel.

  • Provides technical experience needed to perform analyses, processing and user support of various computer systems using standard statistical procedures and techniques.

  • Provide project management guidance and assistance to specific projects and activities.

  • Identify unmet needs, introduce new technologies, and gather feedback from the user community to increase the reliability of the tracking and data collection.

  • Interface with staff as needed to gather project requirements, develop project plan with web team, and help execute plan.

  • Design, develop, document, analyze, create, test and modify computer systems, programs and integrations.

  • Sets up and uses various computer systems and software packages.

  • Implement improvements to development activities to speed development of applications, databases, or software tools.

  • Determine needs and provide IT support for computerized systems supporting activities. Compiles and manages data and assists with quality control.

  • Develop custom computer applications for collecting and analyzing data, including some that interface with commercial and custom-built hardware.

  • Maintain accurate and complete problem tracking and resolution databases.

  • Manage data formatting input and output.

  • Perform quality assurance and quality control; troubleshoot issues with image analysis and quality.

  • Drive collection of new data and the refinement of existing data.

  • Produces various reports, graphs and figures for presentation.

  • Write policies, procedures, and standards; provide training on hardware and software; coordinate and/or set up customer systems.

  • Interface with the statistical programming team to develop programming standards and assist the team with validation and change control documentation.

  • Trains users in applying systems and analysis methods.

  • Educate users in the use of the tools and reports.

  • Provide computing support including troubleshooting, answering technical inquiries from users, and procuring new systems.

  • Consult and collaborate with users to explain new tools and enable them to be adapted to meet specific research needs.

  • Develops new programs and systems as needed.

  • Create system documentation, electronic templates and examples, training materials and presentations.

  • Develop and test web applications.

  • Develop dedicated and efficient computer software using state of the art computer science approaches, including modern programming languages and coed libraries, machine learning, cross-platform programming, and high-performance computing.

  • Develop scripts to automate data processing pipelines.

  • Develop and implement new or major revisions to applications, databases, or software tools Coordinates data storage and mining.

  • Manage a data storage and backup for scientific computers using available resources.

  • Establish and/or maintain local storage and high-speed networks.

  • Manage full lifecycle of web-based applications.

  • Maintain back up and archiving systems to avoid loss of research data.

  • Create data housing structures and workflow.


Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.


The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.


Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com


This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.

Salary Range
$115,000—$125,000 USD