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Sr. Validation Engineer (Smoke Study Validation Services) at 301044 Fresenius Kabi USA, LLC

Compensation · Listed in posting

$80,000 – $100,000/yr

Location
Melrose Park, Illinois
Type
Full-time
Level
mid
Posted

Description

Fresenius Kabi is hiring an onsite, full-time Validation Engineer to provide technical support for equipment, facility, and utility qualification and requalification in a pharmaceutical manufacturing environment. The role leads IQ, OQ, and PQ validation projects, develops protocols, plans, risk assessments, reports, and traceability matrices, conducts smoke/fog studies, investigates deviations, and supports regulatory inspection readiness. It requires a bachelor’s degree in engineering or a scientific field, at least three years of relevant cGMP experience, technical writing and statistical analysis skills, and knowledge of cGMPs, aseptic techniques, and industry standards. The position offers a base salary of $80,000 to $100,000, a 6% bonus target, and medical, dental, and vision coverage.

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