Onsite Validation Engineer – Computer Systems (MES, cGMP)

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

Health benefits: medical, prescription

Dental and vision coverage

Paid vacation and holidays

Employee assistance program

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi USA is seeking a Validation Engineer for an on-site role in Melrose Park, IL. A Bachelor’s degree in science or engineering and at least one year in a cGMP facility are required.

The position focuses on computerized systems validation (MES/EBR, historian QMIB) with strong documentation and regulatory alignment. The role emphasizes collaboration across multiple departments, development of test protocols, and ensuring compliance with cGMP standards.

Qualifications

• Bachelor’s degree in science or engineering is required.
• Minimum of one year of related experience in a cGMP facility and familiarity with FDA regulations.

Responsibilities

• Schedules and executes computer system qualifications per SOPs and documents results.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) incl. protocol prep and final reports.
• Develops and updates validation life cycle documents (URS, FDS, DS, risk assessments, FMEAs).
• Represents Technical Services in teams to specify, install, validate, troubleshoot and maintain systems.

Skills

Technical writing

Verbal communication

Problem solving

Independent worker

Education

Bachelor’s Degree in Science or Engineering

Job description

Fresenius Kabi USA is seeking a Validation Engineer for an on-site role in Melrose Park, IL. A Bachelor’s degree in science or engineering and at least one year in a cGMP facility are required.

The position focuses on computerized systems validation (MES/EBR, historian QMIB) with strong documentation and regulatory alignment. The role emphasizes collaboration across multiple departments, development of test protocols, and ensuring compliance with cGMP standards.