Validation Engineer: cGMP Compliance & Equipment Qualification

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits: medical, prescription

Paid vacation/holiday/personal days

Job summary

Fresenius Kabi USA, LLC seeks a validation professional in Wilson, NC to provide technical support for equipment/system initial validation and requalification, ensuring cGMP compliance. The role involves report writing, data analysis, and working with cross-functional teams to improve plant systems.

The candidate will handle calibration, qualification studies, and deviations, with weekend/off-shift hours possible. Strong documentation and regulatory familiarity are required for success.

Qualifications

• Must understand cGMP practices and regulatory requirements.
• Experience entering controlled areas (Grade D/B/C) and training.
• Ability to write reports clearly and record data accurately.
• Basic understanding of statistical analysis.
• Weekends and off-shift hours may be required.

Responsibilities

• Schedules and executes equipment commissioning, qualification, and requalification per SOPs; coordinates testing and evaluates results.
• Executes validation studies including protocol prep, scheduling, execution, and final reports; presents results to regulators when needed.
• Programs and operates department instruments (e.g., data loggers) for chamber qualifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Part of teams to specify, install, validate, troubleshoot, and maintain systems.
• Conducts deviations and investigates root causes to define corrective/preventive actions.

Skills

cGMP knowledge

Report writing

Data analysis

Validation experience

Tools

Dataloggers

Job description

Fresenius Kabi USA, LLC seeks a validation professional in Wilson, NC to provide technical support for equipment/system initial validation and requalification, ensuring cGMP compliance. The role involves report writing, data analysis, and working with cross-functional teams to improve plant systems.

The candidate will handle calibration, qualification studies, and deviations, with weekend/off-shift hours possible. Strong documentation and regulatory familiarity are required for success.