Senior Quality Engineer: CSV, Data Integrity & Compliance

Johnson & Johnson Co.; Athens (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Engineer focused on Quality Systems in Athens, GA. You will lead validation activities for computerized systems and digital solutions within a regulated environment, collaborating across Quality, Manufacturing, and IT to ensure systems are fit for intended use and maintained in a validated state.

Responsibilities include developing CSV strategies, reviewing validation lifecycle documents, and guiding change control.

Qualifications

• Experience leading validation and quality-system activities.
• Ability to translate regulatory requirements into practical validation plans.
• Strong collaboration with Quality, Manufacturing and IT teams.

Responsibilities

• Provide technical quality leadership for computerized systems and digital solutions in a regulated environment.
• Develop and execute Computerized System Validation strategies with risk-based approaches.
• Review lifecycle documents: validation plans, user requirements, functional specs, risk assessments, test scripts, and validation reports.
• Provide change management guidance on validation strategies based on use, complexity, and risk.
• Oversee implementation, upgrades, and retirement of computerized systems.
• Investigate validation discrepancies and system-related quality issues to support CAPAs.
• Ensure systems remain in a controlled state and data integrity is maintained throughout lifecycle.
• Lead risk assessments and use results to prioritize verification activities.
• Support audits and inspections with documentation and responses.

Skills

Quality systems

Validation (CSV)

Risk-based mindset

Data integrity

Regulatory compliance

Cross-functional collaboration

Tools

GxP

Change control

Audit readiness

Job description

Johnson & Johnson is seeking a Senior Quality Engineer focused on Quality Systems in Athens, GA. You will lead validation activities for computerized systems and digital solutions within a regulated environment, collaborating across Quality, Manufacturing, and IT to ensure systems are fit for intended use and maintained in a validated state.

Responsibilities include developing CSV strategies, reviewing validation lifecycle documents, and guiding change control.