Computer System Validation Engineer 1

  • Posted 9 hours ago | Updated 9 hours ago

Overview

Remote
55
Contract - Independent
Contract - 12 Month(s)
No Travel Required
Unable to Provide Sponsorship

Skills

Data Integrity
Document Management
Documentation
LIMS
Supervision
Software Development
Software Development Methodology
Quality Management
Regulatory Compliance
OQ
PQ
Process Modeling
Project Management
Enterprise Resource Planning
GAMP
GxP
IQ
Agile
Auditing
Collaboration
Computerized System Validation
Work Breakdown Structure
Traceability Matrix
Inspection
Requirements Engineering
Test Scripts
Training
URS
V-Model
Waterfall

Job Details

Title: CSV Engineer 1

Location: Remote

 

About:

The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems.

Key Responsibilities
Assist in the development and execution of validation documentation, including:

· User Requirements Specifications (URS)
· Functional Specifications (FS)
· Validation Plans (VP)
· Test Scripts (IQ/OQ/PQ)
· Traceability Matrices Perform system assessments to determine GxP applicability and validation requirements.
Ensure adherence to Part 11 controls electronic rec…

Collaborate with cross-functional teams to resolve validation issues.

Maintain accurate and complete validation documentation in the designated repository.

Qualifications:

· 2-5 years’ experience with FDA Quality System regulations, standards and processes in process model for software development including:
· Knowledge of procedure or instruction development and document management concepts
· Knowledge of Quality methods e.g. documentation management, training, review or inspection, statistical sampling, internal/external audit, troubleshooting, investigation or analysis tools/techniques
· Knowledge of SDLC development methodology e.g. V-model, GAMP, Agile
· Knowledge of Architecture Standards and concepts, configuration diagrams, infrastructure topology
· Knowledge of Project Management processes and Work Break Down Structures
· Knowledge of requirements engineering, test environments and protocols
· Knowledge of Computer System Validation concepts
· Knowledgeable in project management, work breakdown structure
· Some supervision is required, can create and author deliverables, can provide some training
· Provides input to Manager to determine work priorities
· Works with supervision in application of skills across multiple Business Segments within CAH
 
Preferred Skills
Experience with electronic systems such as LIMS, ERP, or Quality Management Systems.
Knowledge of data integrity principles.
Familiarity with Agile or Waterfall methodologies.

 

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