Senior Validation Engineer — cGMP Compliance Lead

Fresenius Kabi; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Dental & vision

Job summary

Fresenius Kabi in the United States seeks a validation professional responsible for supporting operations through initial validation and requalification of equipment and systems. The role includes coordinating HEPA filter integrity testing, critical area airflow testing, and ensuring adherence to cGMP and change control requirements.

The incumbent provides guidance to validation staff and contractors, participates in equipment improvement initiatives, and contributes to final report approvals.

Qualifications

• Requires strong knowledge of validation principles in a cGMP environment.
• Experience coordinating validation projects and reports (protocols, reports, approvals).
• Familiarity with HEPA testing, airflow testing, and change control processes.

Responsibilities

• Schedule and execute equipment requalifications per SOPs and communicate results.
• Lead validation studies, prepare protocols, manage schedules and reports.
• Present results to Regulatory Agency when necessary.
• Operate qualification instruments for controlled environments.
• Contribute to ongoing development of validation programs to stay compliant.

Skills

Validation engineering

Project management

cGMPs knowledge

Regulatory communications

Tools

Temperature/Humidity dataloggers

Test equipment (smoke generators/photometers/velocity meters)

Job description

Fresenius Kabi in the United States seeks a validation professional responsible for supporting operations through initial validation and requalification of equipment and systems. The role includes coordinating HEPA filter integrity testing, critical area airflow testing, and ensuring adherence to cGMP and change control requirements.

The incumbent provides guidance to validation staff and contractors, participates in equipment improvement initiatives, and contributes to final report approvals.