CSV Engineer — Regulated Systems Validation Specialist

JC Automation; San Lorenzo (PR); On-site; USD 90,000 - 130,000; 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.

You will support the full lifecycle from requirements to validation planning, testing, implementation, and periodic review. You will focus on data integrity, risk-based validation, and documentation, collaborating with Quality, Automation, IT, Engineering, and system owners.

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 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, User Requirements Specifications (URS), Functional/Design Specifications, 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 applicable 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

Strong technical writing

Analytical skills

Documentation

Problem-solving skills

Independent work

Team collaboration

GxP knowledge

Education

Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field

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.

You will support the full lifecycle from requirements to validation planning, testing, implementation, and periodic review. You will focus on data integrity, risk-based validation, and documentation, collaborating with Quality, Automation, IT, Engineering, and system owners.