Validation Engineer — cGMP, Equipment Qualification & Data

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

Job summary

Fresenius Kabi USA is seeking a technically adept professional to provide support for equipment/system initial validation and requalification within our North Carolina facility. The role involves coordinating with multiple groups, ensuring compliance with cGMPs, and contributing to change control as needed.

You will draft protocols, execute validations, analyze data, and prepare final reports for approval while also supporting investigations and continuous improvements of validation programs.

Responsibilities

• Drafts protocols and executes equipment commissioning, qualification, and requalification per SOPs.
• Communicates testing with affected functional groups and evaluates test results.
• Analyzes data, composes final reports, and circulates for approval.
• Presents results to Regulatory Agency when necessary.
• Operates instruments for temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators).
• Participates in validation program improvements to stay current with cGMPs.
• Works on teams to specify, install, validate, troubleshoot, and maintain systems and equipment.
• Investigates validation deviations and performs root-cause analyses to define corrective/preventative actions.

Job description

Fresenius Kabi USA is seeking a technically adept professional to provide support for equipment/system initial validation and requalification within our North Carolina facility. The role involves coordinating with multiple groups, ensuring compliance with cGMPs, and contributing to change control as needed.

You will draft protocols, execute validations, analyze data, and prepare final reports for approval while also supporting investigations and continuous improvements of validation programs.