Onsite Validation Engineer: cGMP Systems & QA

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation and holidays

Health benefits

Job summary

Fresenius Kabi USA in Illinois is seeking a technically skilled professional to provide validation and support for plant systems, equipment, and processes. The role requires executing requalifications, generating reports, and ensuring compliance with cGMP standards in a high-regulation environment.

The candidate will participate in tests and qualifications for new products, process improvements, and change controls, with occasional off-shift hours.

Qualifications

• Bachelor’s degree in a Science or Engineering field.
• Minimum of one year relevant work 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 strongly preferred.

Responsibilities

• Schedules and executes equipment requalifications per SOPs and communicates with affected groups.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) with protocol prep and final report.
• Programs and operates department analytical instruments for qualification testing.
• Develops/improves validation programs to stay current with cGMPs and industry standards.
• Schedules and executes HEPA Filter and Critical Area testing per SOP and records results.
• Represents Technical Services in teams to specify, install, validate, troubleshoot and maintain systems.
• Ensures compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Skills

cGMP knowledge

Statistical analysis

Datalogger programming

QA reporting

Equipment validation

Documentation

Office software

cGMP auditing

Education

Bachelor’s degree in Science or Engineering

Tools

Word

Excel

PowerPoint

Project

Access

Job description

Fresenius Kabi USA in Illinois is seeking a technically skilled professional to provide validation and support for plant systems, equipment, and processes. The role requires executing requalifications, generating reports, and ensuring compliance with cGMP standards in a high-regulation environment.

The candidate will participate in tests and qualifications for new products, process improvements, and change controls, with occasional off-shift hours.