Validation Engineer – cGMP, Data & Reporting

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

Benefits offered by this job

401(k) plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Job summary

Fresenius Kabi in Wilson, NC seeks a technical specialist in equipment validation to support initial qualification and requalification per cGMPs. You will join cross-functional teams, write clear reports, and help ensure compliant, high-performing plant systems.

Some weekends/off-shift hours are required. The role involves conducting validation studies, SOPs, data analysis, and participation in change-control processes.

Qualifications

• Must understand cGMPs and regulatory requirements.
• Ability to write reports clearly and accurately.
• Experience with data analysis and statistical concepts.

Responsibilities

• Drafts protocols and executes equipment commissioning, qualification, and requalification per SOPs.
• Executes validation studies including protocol preparation, scheduling, execution, and final report.
• Programs and operates analytical instruments for controlled temperature/humidity chamber qualifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Participates in teams to specify, install, validate, troubleshoot and maintain systems.
• Conducts validation deviations and investigates root causes to define corrective actions.

Job description

Fresenius Kabi in Wilson, NC seeks a technical specialist in equipment validation to support initial qualification and requalification per cGMPs. You will join cross-functional teams, write clear reports, and help ensure compliant, high-performing plant systems.

Some weekends/off-shift hours are required. The role involves conducting validation studies, SOPs, data analysis, and participation in change-control processes.