Validation Engineer — GMP Equipment Qualification & Impact

Agupdate

Wilmington, Northern (NC, KY)

Hybrid

USD 90,000 - 120,000

Full time

8 days ago

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Benefits offered by this job

Subsidized childcare

Excellent benefits package

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC, seeks a Validation Engineer with a Bachelor’s degree in a scientific or engineering discipline and at least 3 years of GMP experience. Experience with automated filling equipment in sterile manufacturing is a plus.

Responsibilities include IQ/OQ/PQ, SOP development, vendor FATs, and data trending. This role is in the Manufacturing and Formulations Services department and offers opportunities for growth in a rapidly expanding pharmaceutical

Qualifications

Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of experience in GMP lab or manufacturing.
Experience with automated filling equipment, especially in sterile manufacturing, is a plus.
Special consideration given to candidates with advanced degrees in chemistry or related sciences and GMP data review experience.

Responsibilities

Create and execute IQ/OQ/IQ/R for equipment and utilities in manufacturing.
Develop SOPs and training materials for manufacturing equipment.
Perform Factory Acceptance Tests for new equipment at vendor sites.
Monitor ViewLinc and respond to excursions as needed.
Perform data trending, write reports, change requests and deviations.
Communicate with clients, manufacturing, formulations management and quality groups.