Validation Engineer

Fresenius Kabi USA•Melrose Park, IL

12d•$65,000 - $80,000

About The Position

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

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
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.

Nice To Haves

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

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.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities