Validation Engineer – Computer Systems & MES

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, dental and vision benefits

Paid vacation and holidays

Life insurance and disability

Job summary

Fresenius Kabi USA in Melrose Park, IL seeks a Validation Engineer specialized in computerized systems validation with MES and historian experience. You will support manufacturing systems, develop qualification protocols, and ensure cGMP compliance across site operations.

The role requires strong technical writing, effective communication, and project management skills. Collaboration with regional and global teams is essential for success.

Qualifications

• Bachelor’s degree in science or engineering required.
• At least 1 year in a cGMP facility with FDA-regulated products.
• Experience with qualification protocols (IQ/OQ/PQ) and validation reports.
• Strong technical writing and verbal communication skills.
• Knowledge of MES, EBR, and manufacturing systems.

Responsibilities

• Schedules and executes computer system qualifications per SOPs.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products).
• Participates in dry running manufacturing system applications and develops test scenarios.
• Develops and updates URS, FDS, DS, risk assessments, and FMEAs.
• Represents Technical Services in cross-functional teams for validation.
• Authors validation master plans and project plans.
• Provides support for Investigations, Change Controls and Risk Assessments.
• All employees ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems.

Skills

cGMP knowledge

Validation expertise

Technical writing

Effective communication

Project management

Education

Bachelor’s Degree in Science or Engineering

Tools

MES (EBR)

Historian QMIB

Computer systems validation

Job description

Fresenius Kabi USA in Melrose Park, IL seeks a Validation Engineer specialized in computerized systems validation with MES and historian experience. You will support manufacturing systems, develop qualification protocols, and ensure cGMP compliance across site operations.

The role requires strong technical writing, effective communication, and project management skills. Collaboration with regional and global teams is essential for success.