Validation Engineer – Computer Systems & MES Expert

Fresenius Kabi; 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

Personal days

Employee assistance program

Health, dental, vision coverage

Job summary

Fresenius Kabi is seeking a Validation Engineer to specialize in computerized systems validation across MES (EBR), Historian (QMIB), LAB-X and related manufacturing applications. The role focuses on technical and documentation work with cross‑functional collaboration at site, regional, and global levels.

The candidate will develop qualification protocols, perform studies, prepare final reports, and contribute to regulatory interactions.

Qualifications

• Bachelor’s Degree in a Science or Engineering field.
• Minimum of one year of related experience in a cGMP facility.
• Experience with FDA regulations, medical, drug and device products.

Responsibilities

• Schedule and execute computer system qualifications per SOPs.
• Assemble final reports and circulate for approval.
• Develop and update validation documents (URS, FDS, DS, FMEAs).
• Provide technical support for investigations and change controls.
• Ensure compliance with cGMPs and industry standards.

Skills

cGMP knowledge

Analytical skills

Technical writing

Verbal communication

Education

B.S. in Science or Engineering

Tools

MES (EBR)

Historian (QMIB)

OEE concepts

Job description

Fresenius Kabi is seeking a Validation Engineer to specialize in computerized systems validation across MES (EBR), Historian (QMIB), LAB-X and related manufacturing applications. The role focuses on technical and documentation work with cross‑functional collaboration at site, regional, and global levels.

The candidate will develop qualification protocols, perform studies, prepare final reports, and contribute to regulatory interactions.