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Fresenius Kabi: Validation Engineer

Fresenius Kabi

This is a Full-time position in City Of Niagara Falls, NY posted August 25, 2021.

Job Summary Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalifications.

Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control.

Individual must also perform HEPA filter integrity/velocity testing and participates in critical area (class 100) airflow pattern testing.

The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A).

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.

Responsibilities 6.


Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs).

Coordinates and communicates all testing with affected functional groups and evaluates test results.

Analyzes data, composes a final report and circulates for approval.2.

Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation.

Participates in presentation of results to Regulatory Agency when necessary.3.

Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).4.

Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.5.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.6.

Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.7.

Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).


Minimum 4-year degree, preferably in a Science or Engineering field of study; or equivalent industry experience.2.

Analytical datalogger programming, operating, troubleshooting, data-collecting.3.

Generation of reports, deviations or other technical documents.4.

Installation, Operational and Performance Qualification protocol generation and execution.5.

PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.6.

Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.7.

Understanding of statistical analysis tools and methods.8.

1-3 years of related experience in a cGMP facility.9.

Knowledge of cGMP room classifications and HEPA filter testing.10.

Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.

Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.