What are the responsibilities and job description for the CSV Engineer position at MSR Technology Group?
Job Title : Computer System Validation Engineer
Location : Dallas, TX
About the Opportunity :
Our client is looking for a Computer System Validation Engineer to contribute to critical projects ensuring compliance and quality of computerized systems. This role is ideal for a highly skilled professional with a passion for validation and regulatory compliance who thrives in a dynamic, team-oriented environment.
Key Responsibilities :
- Validation Deliverables : Develop, review, and execute comprehensive validation plans, risk assessments, and traceability matrices for computerized systems.
- Documentation Compliance : Author and maintain essential documentation to meet CSV standards and ensure regulatory compliance.
- Validation Processes : Prepare or review critical validation documents, including :
- Validation Strategy Plans
- User Requirement Specifications (URS)
- Functional Specifications, Software Design Specifications, Configuration Documents
- Qualification Protocols (IQ, OQ, PQ) and Test Specifications
- SOPs, Traceability Matrices, and Risk Analyses
- Validation Reports, Change Controls, Deviations, and Event Reports
- Impact Assessments : Analyze proposed changes to systems and determine necessary validation efforts.
- Validation Strategy : Define and execute strategies for the implementation and maintenance of computerized systems.
- Collaboration : Work closely with cross-functional teams, including Information Systems, software assurance, business users, and suppliers, to deliver compliant and successful project outcomes.
- Expert Guidance : Serve as a subject matter expert, providing strategic advice and consultation on all aspects of CSV.
Candidate Requirements :
