CSV Engineer: Regulated Systems Validation & Data Integrity

ADP, Inc.; San Lorenzo (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

JC Automation Corp. is seeking a Computer System Validation (CSV) Engineer to ensure computerized systems in regulated environments are validated and maintained in compliance with regulatory and quality requirements.

They will support the complete lifecycle from requirements definition through periodic reviews. The role emphasizes risk-based validation, data integrity, and documentation, requiring collaboration with Quality, IT, Automation, and Engineering teams, and supporting regulatory

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field.
• Experience with Computer System Validation in pharmaceutical, biotechnology, medical device, or other regulated industries.
• Knowledge of GxP requirements and computerized system lifecycle principles.
• Familiarity with 21 CFR Part 11, data integrity principles, and applicable regulatory guidance.
• Ability to develop, review, and execute validation protocols and technical documentation.
• Knowledge of risk-based validation methodologies.
• Strong technical writing, analytical, documentation, and problem-solving skills.
• Ability to work independently and collaboratively with multidisciplinary teams.

Responsibilities

• Develop and execute computer system validation documentation, including Validation Plans, URS, FDS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Perform risk assessments to determine validation requirements and testing strategies.
• Review and approve system requirements, specifications, and configuration documentation.
• Execute and document validation testing and manage identified discrepancies or deviations.
• Support system implementation, upgrades, changes, patches, and periodic reviews while maintaining the validated state.
• Ensure computerized systems comply with data integrity and electronic records/electronic signature requirements.
• Support Change Controls, Deviations, CAPAs, and investigations related to computerized systems.
• Collaborate with Quality, Automation, IT, Engineering, and system owners throughout the system lifecycle.
• Support regulatory inspections and internal or external audits.

Skills

Technical writing

Analytical

Documentation

Problem-solving

Independent work

Collaborative work

Education

Bachelor’s degree in Engineering/Computing/Life Sciences or related field

Tools

Kneat or similar validation platform

Job description

JC Automation Corp. is seeking a Computer System Validation (CSV) Engineer to ensure computerized systems in regulated environments are validated and maintained in compliance with regulatory and quality requirements.

They will support the complete lifecycle from requirements definition through periodic reviews. The role emphasizes risk-based validation, data integrity, and documentation, requiring collaboration with Quality, IT, Automation, and Engineering teams, and supporting regulatory