Validation Engineer - Onsite, cGMP Compliance & Testing

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

Paid vacation

Paid holidays

Health benefits (medical, dental, and视

Employee assistance program

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL seeks an onsite, full-time specialist to provide technical support for validation and qualification of plant systems, equipment, and processes. You will participate in change control and compliance activities while preparing reports and data analyses.

The role requires a Bachelor’s in Science/Engineering and at least one year of cGMP experience, with familiarity in qualification protocols, data logging, and analytical instrumentation.

Qualifications

• Bachelor's degree in a Science or Engineering field of study required
• Minimum of one year relevant work experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.
• Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
• Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
• PC literate with Word, Excel, PowerPoint, Project, Access competency
• Knowledge of cGMPs, industry guidance, and aseptic techniques

Responsibilities

• Schedules and executes equipment requalifications per SOPs. Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation.
• Programs and operates department analytical instruments to perform controlled temperature/humidity chamber qualifications.
• Develops/improves validation programs to remain current with cGMPs and industry standards.
• Schedules and executes HEPA Filter and Critical Area testing per SOP. Programs and operates test equipment and records results.
• Represents Technical Services in teams to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• All employees are responsible for ensuring compliance to company documents, programs and activities related to HSE and Quality Management Systems.

Skills

cGMP knowledge

Analytical datalogger

Report writing

PC literacy

Statistical 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 seeks an onsite, full-time specialist to provide technical support for validation and qualification of plant systems, equipment, and processes. You will participate in change control and compliance activities while preparing reports and data analyses.

The role requires a Bachelor’s in Science/Engineering and at least one year of cGMP experience, with familiarity in qualification protocols, data logging, and analytical instrumentation.