Senior Validation Engineer - Equipment & Compliance Lead

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

Benefits offered by this job

401(k) plan with company contributions

Medical, dental and vision coverage

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA in Wilson, NC is seeking a Validation Specialist responsible for providing technical support for initial validation and requalification of equipment/systems. The role includes coordinating HEPA/critical area testing, ensuring cGMP compliance, and leading validation projects with a team of professionals.

Salary range is $73,614 to $103,528 with a target bonus of 6%. Benefits include medical, dental, vision, 401(k) contributions, and paid time off; all employment is at-will.

Qualifications

• Comprehensive understanding of cGMPs and regulatory considerations.
• Experience with validation studies and requalification.
• Ability to lead validation projects and teams.

Responsibilities

• Schedule and participate in equipment requalifications per SOPs and communicate results.
• Execute validation studies and prepare/provide final reports.
• Present results to Regulatory Agency when necessary.
• Operate equipment like temperature/humidity dataloggers for chamber qualifications.
• Develop and improve validation programs to stay current with cGMPs.
• Coordinate HEPA filter testing and airflow pattern testing per SOP.
• Represent Validation department in cross-functional teams.
• Investigate deviations and identify corrective and preventive actions.

Skills

cGMP knowledge

Validation techniques

Project management

Regulatory interactions

Tools

Temperature/humidity dataloggers

Photometers

Velocity meters

Job description

Fresenius Kabi USA in Wilson, NC is seeking a Validation Specialist responsible for providing technical support for initial validation and requalification of equipment/systems. The role includes coordinating HEPA/critical area testing, ensuring cGMP compliance, and leading validation projects with a team of professionals.

Salary range is $73,614 to $103,528 with a target bonus of 6%. Benefits include medical, dental, vision, 401(k) contributions, and paid time off; all employment is at-will.