CSV ENGINEER | COLUMBUS, OH (REMOTE)

Overview

Remote
On Site
USD 55-60
Contract - Independent
Contract - 12 Month(s)

Skills

Computer System Validation
Test Scripts
FDA GMP
Structures
Breakdown
Agile & Waterfall Methodologies
ERP Implementations
IQ Navigator
PQQ

Job Details

ONLY 1099

JOB TITLE: CSV ENGINEER

JOB DURATION: 1 YEAR

JOB LOCATION: COLUMBUS, OH (REMOTE)

EXPERIENCE: 8+ YEARS

VISA: , - 1099

Job Domain

Healthcare Industry

Job Description

Role: 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 MatricesPerform system assessments to determine GxP applicability and validation requirements.
  • Ensure adherence to Part 11 controls electronic records and signatures.
  • 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 a 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, and infrastructure topology
  • Knowledge of Project Management processes and Work Breakdown 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 and can provide some training
  • Provides input to the Manager to determine work priorities
  • Works with supervision in the application of skills across multiple Business Segments within CAHPreferred 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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