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From Home Computer System Validation Jobs in Washington

... 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 ...

... from healthcare data, supporting critical decision-making within the military and defense health ... systems. * Bachelor's degree in Business, Data Science, Computer Science or a related field.

Network Computer System Administrator

Mclean, VA · On-site

$70K - $95K/yr

Overview The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...

The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to develop ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...

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From Home Computer System Validation information

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

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Infographic showing various From Home Computer System Validation job openings in Washington as of July 2026, with employment types broken down into 1% As Needed, 81% Full Time, 16% Part Time, and 2% Contract. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution.
Computer Systems Validation Engineer

Computer Systems Validation Engineer

Orion Innovation

Washington, DC

Other

Posted 17 days ago


Job description

PURPOSE AND SCOPE OF POSITION:

The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant client procedures and regulations.

DUTIES AND RESPONSIBILITIES:

  • Author, review and/or approve applicable CSV documentation
  • Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
  • Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
  • Other related duties as assigned

Skills

MES experience Required

unicorn

Syncade.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Ability to effectively communicate with both technical and non-technical team members.
  • Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
  • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
  • Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
  • Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
  • Strong technical and problem-solving skills and the ability to work independently.
  • Demonstrated success working in a high-performing, business results-driven environment.
  • Understanding of computer system validation.
  • Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
  • Understanding of computer system validation (CSV).

Education and Experience:

  • Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
  • Strong knowledge on Manufacturing Execution System (MES) validation.
  • Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
  • Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)