Validation Engineer

Fresenius Kabi USA • Melrose Park, IL

1d • $65,000 - $80,000 • Onsite

About The Position

This is an onsite, full-time salaried role. The Validation Engineer is responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. The role involves participating in process and equipment improvement teams focused on enhancing the compliance and performance of plant systems, while adhering to regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). Key duties include writing clear, concise, and accurate reports, accurately recording data, and applying basic statistical analysis. Periodic requirement for weekends and off-shift hours. All employees are responsible for ensuring compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Requirements

• 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.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Nice To Haves

• Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
• Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
• 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.

Responsibilities

• Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs).
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Assembles and composes the final report and circulates for approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level