Computer Systems Validation Engineer (Onsite)

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal休

Health benefits: medical, prescription

Dental and vision coverage

Employee assistance program

Life insurance

Job summary

Fresenius Kabi in Melrose Park, IL is hiring a Validation Engineer for full-time onsite work. The role centers on computer systems validation within MES and related manufacturing apps. Strong documentation and regulatory experience are required.

The candidate will develop and execute qualification protocols, maintain validation documents, and support multiple departments with technical and compliance needs. Excellent communication is essential.

Qualifications

• Bachelor's degree in Science or Engineering.
• Experience in a cGMP facility and FDA regulations is preferred.
• Qualification protocol generation and execution experience.
• Knowledge of MES, Historian, and manufacturing applications.
• Excellent written and verbal communication skills.

Responsibilities

• Schedule and execute computer system qualifications per SOPs; coordinate testing with functional groups and finalize reports.
• Perform validation studies (utility, equipment, cleaning, process, computer, and new products) and present results to regulators when needed.
• Contribute to dry runs for manufacturing system applications and develop test scenarios and scripts.
• Develop and update validation documents (URS, FDS, DS, risk assessments, FMEAs, protocols).
• Improve validation programs to stay current with cGMPs and industry standards.
• Represent Technical Services in teams to specify, install, validate, troubleshoot, and maintain systems.

Skills

Technical writing

Verbal communication

Project management

Education

Bachelor’s Degree in Science or Engineering

Tools

MES (EBR)

Historian (QMIB)

LAB-X

Job description

Fresenius Kabi in Melrose Park, IL is hiring a Validation Engineer for full-time onsite work. The role centers on computer systems validation within MES and related manufacturing apps. Strong documentation and regulatory experience are required.

The candidate will develop and execute qualification protocols, maintain validation documents, and support multiple departments with technical and compliance needs. Excellent communication is essential.