Overview
Remote
On Site
Full Time
Skills
URS
Risk Assessment
Regulatory Affairs
Traceability Matrix
IQ
OQ
PQ
Scripting
Collaboration
Biostatistics
Quality Assurance
Change Control
GAMP
Auditing
RStudio
Management
Clinical Data Management
Meta-data Management
Regulatory Compliance
Computer Science
Life Sciences
Computerized System Validation
GxP
GitLab
EDC
Data Integrity
Documentation
Analytical Skill
Communication
Software Development Methodology
Agile
DevOps
Clinical Trials
Training
Job Details
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 21 CFR Part 11, Annex 11, ICH E6(R2), GAMP 5, 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.
- Bachelor's degree in computer science, Life Sciences, or related field.
- 5+ 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 (21 CFR Part 11), 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.
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