Senior Validation Engineer: cGMP Testing & Compliance Lead

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

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Bonus plan

Job summary

Fresenius Kabi in Wilson, NC seeks a validation specialist responsible for equipment/system initial validation and requalification, ensuring compliance with cGMPs and change control. You will coordinate HEPA filter integrity/velocity testing and testing of critical airflow patterns as part of plant validations.

The role includes directing validation team members and contractors, leading testing activities, and presenting results to regulators when needed.

Qualifications

• Comprehensive understanding of cGMPs and ability to enter controlled areas.
• Experience leading validation tests and coordinating project activities.
• Ability to coordinate testing with multiple functional groups and interpret results.

Responsibilities

• Schedules and participates in equipment requalifications per SOPs and communicates tests across groups.
• Executes validation studies, prepares protocols, and drafts final reports.
• Presents results to Regulatory Agency when necessary.
• Operates temperature/humidity dataloggers to perform chamber qualifications.
• Develops/improves validation programs to stay current with cGMPs.

Skills

cGMP knowledge

supervisory experience

validation testing

HEPA testing

Tools

Temperature/Humidity dataloggers

Job description

Fresenius Kabi in Wilson, NC seeks a validation specialist responsible for equipment/system initial validation and requalification, ensuring compliance with cGMPs and change control. You will coordinate HEPA filter integrity/velocity testing and testing of critical airflow patterns as part of plant validations.

The role includes directing validation team members and contractors, leading testing activities, and presenting results to regulators when needed.