Validation Engineer — Onsite GMP & Equipment Validation

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

Benefits offered by this job

401(k) plan

Paid vacation & holidays

Employee assistance program

Health benefits

Dental coverage

Vision coverage

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a qualified professional for on-site validation duties. The role focuses on initial validation and requalification of equipment, systems, and processes within a cGMP framework.

Strong data collection and reporting skills are essential for accurate documentation and regulatory compliance. The candidate will participate in cross-functional teams, prepare reports, and ensure testing aligns with SOPs.

Qualifications

• Bachelor’s degree in science or engineering.
• 1 year of experience in a cGMP regulated industry.
• Experience with IQ/OQ/PQ protocol generation and execution preferred.

Responsibilities

• Schedule and execute equipment requalifications per SOPs.
• Coordinate testing with affected groups and evaluate results.
• Assemble final reports and circulate for approval.
• Develop and maintain validation programs to stay current with cGMPs.
• Operate instruments and collect data for qualification studies.

Skills

Requalification testing

cGMP

Analytical instruments

Data analysis

Report writing

SOP adherence

Team collaboration

Education

Bachelor's degree in Science/Engineering

Tools

Excel

Word/PowerPoint

Access

Project

Job description

Fresenius Kabi in Melrose Park, IL is seeking a qualified professional for on-site validation duties. The role focuses on initial validation and requalification of equipment, systems, and processes within a cGMP framework.

Strong data collection and reporting skills are essential for accurate documentation and regulatory compliance. The candidate will participate in cross-functional teams, prepare reports, and ensure testing aligns with SOPs.