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Computer System Validation Csv Remote Jobs in Washington

INflow Federal

Data Engineer

Arlington, VA · Remote

$131K - $158K/yr

Bachelor's degree in Computer Science, Information Systems, or a related technical field, or ... Must have valid driver's license and transportation. This is subject to change at the direction of ...

INflow Federal

Data Engineer

Arlington, VA · Remote

$117K - $140K/yr

Bachelor's degree in Computer Science, Information Systems, or a related technical field, or ... Must have valid driver's license and transportation. This is subject to change at the direction of ...

INflow Federal

Data Engineer

Arlington, VA · On-site +1

$131K - $158K/yr

Bachelor's degree in Computer Science, Information Systems, or a related technical field, or ... Must have valid driver's license and transportation. This is subject to change at the direction of ...

Paragone Solutions, Inc.

Jr. Azure Technician

Mclean, VA · Remote

$22 - $30.25/hr

Provide remote and onsite technical support to end users, resolving incidents efficiently while ... Skilled in computer system and network support, including standalone systems and peripheral devices.

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Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
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Computer System Validation Csv Remote jobs near you
Computer & Information Systems Manager

Computer & Information Systems Manager

eTelligent Group LLC

Washington, DC • Remote

Other

Posted 19 days ago

Job description

Place of Performance: Remote

Citizenship: US Citizen (MUST)

Security Clearance: Must be eligible to possess MBI (IRS Background Investigation) clearance. Active IRS MBI clearance is preferred.

Role Summary:

The Computer & Information Systems Manager is the technical execution lead for the computer security review mission. This person leads the assessor team that performs system configuration checks, automated and manual compliance scans, and findings documentation, and oversees the evaluation of agency security submissions.

 

Key Responsibilities:

  • Lead execution of Computer Security Reviews (Task 4): pre-review scoping (PSE), SCSEM execution, Nessus/automated scanning, findings documentation, and completion of Section H of the Safeguard Review Report (SRR).
  • Oversee evaluation of agency submissions (Task 5): Corrective Action Plans (up to 450/yr), Technical Inquiries (up to 350/yr), Safeguards Security Reports (up to 300/yr), and Notifications (up to 125/yr).
  • Support development and semiannual update of SCSEMs and automated evaluation files (Nessus audit / SCAP) under Task 6.
  • Manage and direct technical assessor staff - assign work, ensure quality, and develop the team.
  • Ensure accuracy, traceability, and consistency of findings against Publication 1075, NIST SP 800-53, CIS Benchmarks, and DISA STIGs.

 

Core Experience (Required):

  • Demonstrated experience with federal government cybersecurity audits and assessments, including implementing security controls, configuration changes, software/hardware updates, and vulnerability management.
  • Hands-on assessment experience across multiple platforms - mainframe (RACF/ACF2); Windows/Linux/UNIX/Solaris/macOS; virtualization (VMware, Hyper-V, Docker, OpenShift, Kubernetes); cloud (AWS, Azure/M365, Salesforce, Google - FedRAMP); networking devices; and encryption standards.
  • Experience executing SCSEMs and automated compliance scanning (e.g., Nessus, SCAP-based audit content).
  • Demonstrated experience in IT/cybersecurity project and personnel management.

 

Minimum Education: High School Diploma or higher.

Certifications / Licenses (minimum of ONE of the following):

  • CASP+ CE CCNP Security CISA CISSP (or Associate) GCED GCIH CCSP CISM GSLC CCISO HCISPP CEH CySA+/CSA+ GSNA CFR PenTest+

In lieu of a certification, graduation from a minimum 2-year IT/Cybersecurity program at an accredited college or university may be substituted.

Preferred: Prior FTI/Safeguards review experience; SCSEM/STIG/CIS authoring experience; bachelor's degree.

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