Onsite Validation Engineer – GMP & QA Impact

RXinsider LTD.; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation/holidays/personal days

Health, dental and vision coverage

Employee assistance program

Life insurance & disability

Job summary

Fresenius Kabi is seeking an on-site, full-time professional to support validation and qualification activities across plant systems. The role requires coordination of testing with multiple functional groups and producing clear final reports, with emphasis on cGMP compliance.

The candidate should have a bachelor’s degree in science or engineering and at least one year in a cGMP setting, with strong data analysis and documentation skills. Weekend/on-call hours may be required.

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
• Understanding of statistical analysis tools and methods.
• Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools & techniques

Responsibilities

• Schedules and executes equipment requalifications per SOPs and coordinates testing with affected groups.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) and presents results to regulatory agencies when necessary.
• Programs and operates department analytical instruments to perform controlled 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 and records results.
• Represents Technical Services in teams to specify, install, validate and maintain systems and processes.
• All employees must ensure compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Skills

Data analysis

Report writing

Datalogger programming

QA processes

Analytical skills

MS Office

Education

Bachelor’s degree in Science or Engineering

Tools

Dataloggers

Smoke generators

Photometers

Velocity meters

Job description

Fresenius Kabi is seeking an on-site, full-time professional to support validation and qualification activities across plant systems. The role requires coordination of testing with multiple functional groups and producing clear final reports, with emphasis on cGMP compliance.

The candidate should have a bachelor’s degree in science or engineering and at least one year in a cGMP setting, with strong data analysis and documentation skills. Weekend/on-call hours may be required.