Onsite Validation Engineer – cGMP & Equipment

301044 Fresenius Kabi USA, LLC; 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 insurance

Paid time off

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL, is seeking an on-site, full-time Validation Specialist. The role focuses on equipment/system/process qualification, requalifications, and report generation under cGMP. Final reports, test coordination, and approvals are part of daily duties; weekend/off-shift hours may be required.

Requires a Bachelor’s degree in Science or Engineering and at least one year in a cGMP environment. Strong documentation, data analysis, and IQ/OQ/PQ familiarity preferred.

Qualifications

• Bachelor’s degree required in Science or Engineering or related field.
• Minimum of one year of experience in a cGMP regulated industry.
• Experience generating reports, deviations, or other technical documents.
• Experience with IQ/OQ/PQ protocol generation and execution preferred.
• Analytical datalogger programming and data collection experience is a plus.
• Knowledge of cGMPs, validation concepts, and regulatory requirements.

Responsibilities

• Schedules and executes equipment requalifications per SOPs.
• Coordinates and communicates testing with affected groups and evaluates results.
• Assembles and circulates final reports for approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, new products) including protocol prep and final report.
• Presents results to Regulatory Agencies when necessary.
• Operates analytical instruments and dataloggers for qualification activities.
• Develops/improves validation programs to stay current with cGMPs and industry standards.
• Schedules and executes HEPA and Critical Area testing per SOP.
• Represents Technical Services in cross-functional teams.

Skills

cGMP experience

Technical report writing

IQ/OQ/PQ protocols

Datalogger programming

Office software

Statistical analysis

Validation knowledge

Root-cause analysis

Education

Bachelor’s degree in Science or Engineering

Tools

Word

Excel

PowerPoint

Project

Access

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL, is seeking an on-site, full-time Validation Specialist. The role focuses on equipment/system/process qualification, requalifications, and report generation under cGMP. Final reports, test coordination, and approvals are part of daily duties; weekend/off-shift hours may be required.

Requires a Bachelor’s degree in Science or Engineering and at least one year in a cGMP environment. Strong documentation, data analysis, and IQ/OQ/PQ familiarity preferred.