Onsite Validation Engineer: cGMP & Equipment Testing

Fresenius SE & Co. KGaA; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Health benefits

Paid time off

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a technically skilled professional to support equipment/system validation and requalification in a cGMP environment. This onsite, full‑time role requires coordinating testing and preparing clear final reports to support compliance.

Responsibilities include executing validation studies, operating dataloggers, developing validation programs, and collaborating with cross‑functional teams to improve plant systems while maintaining regulatory standards.

Qualifications

• Bachelor’s degree in a Science or Engineering field is required.
• Minimum of one year of experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.
• Experience with Installation, Operational and Performance Qualification protocol generation and execution preferred.
• Analytical datalogger programming, operating and data collection preferred.
• Proficiency with standard office software (Word, Excel, PowerPoint, Project, Access).
• Knowledge of cGMPs, industry guidance, and aseptic techniques.
• Understanding of statistical analysis tools and methods.

Responsibilities

• Schedules and executes equipment requalifications per SOPs; coordinates testing and compiles final report.
• Executes validation studies (utility, equipment, cleaning, process, computer, new products) with protocol preparation and reporting.
• Operates analytical instruments and dataloggers for controlled environment qualifications.
• Develops/improves validation programs to stay current with cGMPs and industry standards.
• Performs HEPA/critical area testing per SOP and records results.
• Participates in cross-functional teams to specify, install, validate, troubleshoot and maintain systems.
• Ensures compliance with Health, Safety, Environment, Energy and Quality Management Systems.

Skills

Analytical thinking

Report writing

Statistical analysis

cGMP knowledge

Education

Bachelor’s degree in Science or Engineering

Tools

Microsoft Office Suite

Datalogger programming tools

Job description

Fresenius Kabi in Melrose Park, IL is seeking a technically skilled professional to support equipment/system validation and requalification in a cGMP environment. This onsite, full‑time role requires coordinating testing and preparing clear final reports to support compliance.

Responsibilities include executing validation studies, operating dataloggers, developing validation programs, and collaborating with cross‑functional teams to improve plant systems while maintaining regulatory standards.