Validation Engineer – GMP Equipment Qualification

NCSL International

Wilmington, Northern (NC, KY)

Hybrid

USD 85,000 - 120,000

Full time

3 days ago

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Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Validation Engineer with a Bachelor's degree or higher in a scientific or engineering discipline and at least 3 years of GMP lab or manufacturing experience.

Responsibilities include developing and executing IQ/OQ/PQ for equipment, writing SOPs and training materials, performing FATs, monitoring excursions with ViewLinc, data trending, and preparing deviation reports and change requests.

Qualifications

Bachelor's degree or higher in a scientific or engineering discipline with 3 years of experience in a GMP laboratory or manufacturing environment.
Special consideration given to candidates with experience with automated filling equipment in sterile manufacturing.

Responsibilities

Create and execute IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications.
Develop SOPs and training materials for manufacturing equipment.
Perform Factory Acceptance Tests for new equipment at vendor sites and monitor.
ViewLinc excursions, perform data trending, write reports, change requests, and deviations; communicate with clients and cross-functional teams.