Validation Engineer – Computerized Manufacturing Systems

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits: medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi USA, LLC is seeking a Validation Engineer onsite in Melrose Park, IL to specialize in computerized systems validation within manufacturing. The role focuses on MES (EBR), historian QMIB, and related applications, with emphasis on documentation and regulatory alignment.

You will collaborate across departments, develop qualification protocols, and maintain cGMP-compliant processes. The position requires strong technical writing, communication, and the ability to manage multiple

Qualifications

• Bachelor's Degree in a Science or Engineering field.
• Minimum of one year of related experience in a cGMP facility with FDA regulations.
• Installation, Operational and Performance Qualification protocol generation and execution.
• Knowledge of cGMPs and aseptic techniques.
• Excellent technical writing and verbal communication skills.
• Understanding of MES(EBR), historian, OEE, and other manufacturing applications.
• PC literacy with Word, Excel, PowerPoint, Project, Access.
• Ability to work independently and manage multiple tasks.

Responsibilities

• Schedules and executes computer system qualifications per SOPs.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Assembles and composes the final report and circulates for approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products).
• Presents results to Regulatory Agency when necessary.
• Develops and updates validation documents (URS, FDS, DS, risk assessments, FMEAs).
• Develops/improves validation programs to remain current with cGMPs and industry standards.
• Represents Technical Services in cross-functional teams to specify, install, validate, troubleshoot and maintain systems.
• Authors validation master plans and validation project plans outlining qualification requirements.
• Authors the documentation for MES(EBR), Historian(QMIB), and manufacturing infrastructure.
• Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments.
• All employees are responsible for compliance with Health, Safety, Environment, and Quality Management Systems.

Skills

Technical writing

Validation engineering

cGMP knowledge

Project management

Communication

Education

Bachelor's Degree in Science or Engineering

Tools

Excel

Word

PowerPoint

MS Project

Access

Job description

Fresenius Kabi USA, LLC is seeking a Validation Engineer onsite in Melrose Park, IL to specialize in computerized systems validation within manufacturing. The role focuses on MES (EBR), historian QMIB, and related applications, with emphasis on documentation and regulatory alignment.

You will collaborate across departments, develop qualification protocols, and maintain cGMP-compliant processes. The position requires strong technical writing, communication, and the ability to manage multiple