Senior Validation Engineer — cGMP & Requalification Lead

Fresenius Kabi; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation & holidays

Health benefits

Job summary

Fresenius Kabi in Wilson, NC seeks a Validation Specialist to provide technical support for equipment/system initial validation and requalification. You will coordinate HEPA testing, critical area airflow studies, and stay current with cGMP requirements while supervising validation staff and contractors.

The role includes project management of validation studies, protocol development, testing coordination, and presenting results to regulatory bodies as needed.

Qualifications

• Comprehensive understanding of cGMPs.
• Certified to enter controlled areas of the plant.
• Experience coordinating validation activities and teams.
• Project management or technical reviewer experience preferred.

Responsibilities

• Schedule and participate in equipment requalifications and testing with affected groups.
• Execute validation studies and prepare protocols, schedules, and final reports.
• Present results to Regulatory Agencies when necessary.
• Operate and program monitoring instruments for chamber qualifications and analyses.
• Develop and improve validation programs to stay current with cGMPs.
• Lead testing of HEPA filters and critical areas and document results.
• Collaborate with teams to install, validate, troubleshoot and maintain systems.

Job description

Fresenius Kabi in Wilson, NC seeks a Validation Specialist to provide technical support for equipment/system initial validation and requalification. You will coordinate HEPA testing, critical area airflow studies, and stay current with cGMP requirements while supervising validation staff and contractors.

The role includes project management of validation studies, protocol development, testing coordination, and presenting results to regulatory bodies as needed.