Computer System Validation Analyst – R Studio

4 days ago

Montclair, Virginia, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Management, Biostatistics, IT, and QA teams to gather requirements and ensure system compliance. Coordinate and document test evidence in systems such as Val Genesis, Kneat, or other e-validation platforms. Perform gap assessments, periodic reviews, and change control assessments for validated systems. Ensure compliance with CFR Part , Annex , ICH E(R), GAMP , and FDA CSA Guidance. Support audit readiness by maintaining validation documentation and providing responses to internal/external auditors. We are seeking a Computer System Validation (CSV) Engineer with strong experience validating statistical programming environments (R Studio), source code management systems (GitLab), and Clinical Data Management Systems such as Metadata Rave EDC. The ideal candidate will be responsible for ensuring GxP compliance, data integrity, and adherence to Computer Software Assurance (CSA) principles throughout the validation lifecycle. Requirements: Bachelor's degree in computer science, Life Sciences, or related field. + years of experience in Computer System Validation in a regulated GxP environment. Hands-on validation experience with, GitLab, and Medidata Rave EDC. Strong understanding of FDA regulations ( CFR Part ), data integrity, and CSA methodology. Experience with electronic validation lifecycle systems (Val Genesis, Kneat, etc.). Strong documentation, analytical, and communication skills. Knowledge of SDLC methodologies including Agile/DevOps validation frameworks. Familiarity with clinical trials data and statistical programming environments. CSA training or certification is a plus.

  • Computer System Validation Specialist

    4 days ago

    Montclair, Virginia, United States beBeeValidation Full time

    Job Title: The ideal candidate will be responsible for ensuring GxP compliance, data integrity, and adherence to Computer Software Assurance (CSA) principles throughout the validation lifecycle. Responsibilities: Lead validation planning, risk assessment, and execution for statistical programming environments, source code management systems, and Clinical...

  • Computer System Validation Engineer

    2 weeks ago

    Montclair, Virginia, United States Katalyst HealthCares & Life Sciences Full time

    Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance...

  • IT Validation Services Specialist

    15 hours ago

    Montclair, Virginia, United States beBeevalidation Full time

    Job Title: IT Validation Services SpecialistDescription:We are seeking a skilled IT validation services specialist to join our team. The ideal candidate will have a strong background in computer system validation, change management and systems development life cycle methodologies.Responsibilities:

  • Validation Lead, SAP S4 HANA

    1 week ago

    Montclair, Virginia, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/ HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: ...

  • Bioinformatics Analyst II

    6 days ago

    Montclair, Virginia, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Design, build, document, and maintain custom state of the art RNAseq and other OMICs data-analysis pipelines and front-end tools for a large user base. Detect and resolve software bugs and performance issues. Provide on-demand technical support for applications. Educate and train colleagues in usage of these tools. Containerize...

  • Senior Validation Manager SAP S/4 HANA

    1 week ago

    Montclair, Virginia, United States beBeeValidation Full time

    Job DescriptionWe are seeking a seasoned professional to lead our validation team in a strategic, risk-based approach. This individual will be responsible for optimizing legacy computer system documentation and ensuring compliance with all project requirements.The ideal candidate will have expertise in computer system validation, good documentation...

  • Senior Manufacturing Systems Expert

    7 days ago

    Montclair, Virginia, United States beBeeManufacturing Full time

    The position of Senior Manufacturing Systems Expert is a critical role in our organization. The ideal candidate will be responsible for leading a team of internal and external professionals, geographically dispersed, to design and implement new manufacturing systems.The successful candidate will have extensive experience in regulated manufacturing,...

  • Data Analysis Specialist

    5 days ago

    Montclair, Virginia, United States beBeeBioinformatics Full time

    Job Title: Data Analysis SpecialistWe are seeking a skilled Data Analysis Specialist to join our international bioinformatics team.About the Role:The successful candidate will be responsible for designing, building, and maintaining custom state-of-the-art data analysis pipelines and front-end tools for large user bases. This includes detecting and resolving...

  • Chief Data Insights Specialist

    1 week ago

    Montclair, Virginia, United States beBeeData Full time

    Job DescriptionWe are seeking a skilled Data Analyst to join our team in the Scientific Programming department. As a key member of our team, you will be responsible for providing support to the analysis and management of our clinical trials.Your primary focus will be on developing and maintaining reporting solutions within the context of Translational and...

  • Chief Statistical Data Analyst

    16 hours ago

    Montclair, Virginia, United States beBeeStatistical Full time

    Senior Statistical Programming LeaderAbout the Role:We are seeking an experienced Senior Statistical Programmer to lead our team in delivering high-quality statistical programming solutions. The successful candidate will be responsible for managing complex projects, resolving programming issues, and ensuring timely delivery of results.Lead projects with...