Onsite Validation Engineer: cGMP & Process Testing

freseniusglobal; United States; On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation and holidays

Health benefits

Wellness program

Job summary

Fresenius Kabi is seeking a technically skilled professional for an onsite, full-time role focused on validation and qualification of plant systems. The position entails requalifications, protocol development, data analysis, and clear reporting within a regulated environment.

The role requires a Bachelor's degree in Science or Engineering and at least one year in a cGMP setting, with familiarity in QA/documentation and analytical instrumentation.

Qualifications

• Bachelor's degree in a Science or Engineering field 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 and data collection experience preferred.
• PC literate with Word, Excel, PowerPoint, Project, Access competency.

Responsibilities

• Schedules and executes equipment requalifications per SOPs and communicates testing results.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) including protocol and final report prep.
• Operates department analytical instruments and performs chamber qualifications.
• Develops or improves validation programs to stay current with cGMPs and industry standards.
• Schedules and conducts HEPA and CriticalArea testing per SOP and maintains equipment.
• Represents Technical Services in teams to specify, install, validate, troubleshoot and maintain systems.

Skills

cGMP knowledge

Dataloggers

Documentation

Statistical analysis

Office software

Education

Bachelor's degree in Science or Engineering

Tools

SOPs

Job description

Fresenius Kabi is seeking a technically skilled professional for an onsite, full-time role focused on validation and qualification of plant systems. The position entails requalifications, protocol development, data analysis, and clear reporting within a regulated environment.

The role requires a Bachelor's degree in Science or Engineering and at least one year in a cGMP setting, with familiarity in QA/documentation and analytical instrumentation.