CSV Engineer

JC Automation Corp.; San Lorenzo (PR); Ibrido; USD 85.000 - 125.000; Tempo pieno

Descrizione del lavoro

JC Automation Corp. is seeking a Computer System Validation Engineer to ensure computerized systems in regulated environments are properly validated and maintained in compliance with quality standards.

Responsibilities include creating validation documentation, performing risk assessments, and supporting system lifecycle activities from requirements through periodic reviews. The role emphasizes data integrity and regulatory compliance within pharmaceutical-focused industries.

Competenze

• Knowledge of GxP and lifecycle principles.
• Ability to develop, review, and execute validation protocols and documentation.
• Strong written communication and documentation skills.
• Experience in regulated environments (pharma/biotech/medical devices).

Mansioni

• Develop and execute CSV documentation: IQ/OQ/PQ, validation plans, URS, protocols, and traceability matrices.
• Perform risk assessments to define validation scope and testing.
• Review requirements, specs, and configuration documentation.
• Execute and document validation testing and manage deviations.
• Support system implementation, upgrades, and periodic reviews while maintaining validated state.
• Ensure data integrity and 21 CFR Part 11 compliance.
• Assist with change controls, deviations, CAPAs, and audits.
• Collaborate with Quality, IT, Engineering, and system owners across lifecycle.
• Support regulatory inspections and internal/external audits.

Conoscenze

GxP knowledge

21 CFR Part 11

Risk-based validation

Technical writing

Regulatory compliance

Independent & collaborative work

Formazione

Bachelor’s degree in Engineering or related field

Strumenti

Kneat

Descrizione del lavoro

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

A Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments are properly validated and maintained in compliance with applicable regulatory and quality requirements. They support the complete system lifecycle, including requirements definition, risk assessment, validation planning, testing, implementation, and periodic review.

Focus: Focuses on the validation and lifecycle management of computerized systems to ensure data integrity, regulatory compliance, system reliability, and continued validated state. Emphasizes documentation, risk-based validation, testing, and compliance with pharmaceutical industry standards.

RESPONSIBILITIES

• 1. 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.
• 2. Perform risk assessments to determine validation requirements and testing strategies.
• 3. Review and approve system requirements, specifications, and configuration documentation.
• 4. Execute and document validation testing and manage identified discrepancies or deviations.
• 5. Support system implementation, upgrades, changes, patches, and periodic reviews while maintaining the validated state.
• 6. Ensure computerized systems comply with applicable data integrity and electronic records/electronic signature requirements.
• 7. Support Change Controls, Deviations, CAPAs, and investigations related to computerized systems.
• 8. Collaborate with Quality, Automation, IT, Engineering, and system owners throughout the system lifecycle.
• 9. Support regulatory inspections and internal or external audits.

REQUIREMENTS & QUALIFICATIONS

Required

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

Preferred

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