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Katalyst CRO

Senior Validation Engineer

Katalyst CRO, Salt Lake City, Utah, United States, 84193

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Senior Validation Engineer Location: North Salt Lake, UT | Salary: $64,000.00 – $83,000.00 (3 days ago)

Responsibilities

Develop and execute validation strategies

Lead Process Validation & PPQ activities

Perform C&Q for equipment, utilities, and facility systems

Run risk and gap assessments

Maintain equipment master data and support change controls

Execute floor-level validation in GMP cleanrooms

Coordinate sampling and data collection

Support recipe authoring, data trending, and automation needs

Train and guide cross‑functional teams

Qualifications

Bachelor's in Engineering

5+ years in biopharma validation/process engineering

Strong process validation & equipment qualification experience

cGMP, FDA/EMA, ICH Q7/Q10 knowledge

MES, automation, LIMS exposure

Cleanroom and hands‑on lab skills

Strong communication & documentation abilities

Seniority level Associate

Employment type Contract

Job function Pharmaceutical Manufacturing

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