CSV Engineer

Summary

JC Automation provides automation, control systems integration, information technology, system integration, and regulatory compliance services for life science manufacturing. The CSV Engineer validates and maintains computerized systems in regulated environments by managing lifecycle activities, documentation, risk assessments, testing, implementation, and compliance. The role also collaborates with cross-functional teams and supports inspections, audits, changes, deviations, and investigations.

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

• 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
• Knowledge of GAMP 5 methodology and risk-based Computer System Assurance/Validation approaches
• Experience with PLC, SCADA, HMI, DCS, MES, LIMS, ERP, historians, or manufacturing computerized systems
• Experience with electronic validation/documentation platforms such as Kneat or similar systems
• Familiarity with ALCOA+ and data integrity requirements
• Experience supporting regulatory inspections or audits
• Knowledge of change control, deviation, CAPA, and quality management processes

Qualifications

Must Haves

• 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

Nice to Haves

• Knowledge of GAMP 5 methodology and risk-based Computer System Assurance/Validation approaches
• Experience with PLC, SCADA, HMI, DCS, MES, LIMS, ERP, historians, or manufacturing computerized systems
• Experience with electronic validation/documentation platforms such as Kneat or similar systems
• Familiarity with ALCOA+ and data integrity requirements
• Experience supporting regulatory inspections or audits
• Knowledge of change control, deviation, CAPA, and quality management processes