Validation Engineer – GMP Equipment & Systems

Quality Chemical Laboratories

Wilmington (NC)

On-site

USD 85,000 - 115,000

Full time

6 hours ago
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Job summary

Quality Chemical Laboratories in Wilmington, NC seeks a Validation Engineer to lead equipment qualification and process validation in a GMP setting. Responsibilities include IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and facilities.

You will develop SOPs and training materials to support manufacturing operations and perform FA T at vendor sites. Experience with ViewLinc for excursions and data trending, plus strong communication with management and the

Qualifications

  • Bachelor’s degree or higher in scientific or engineering discipline required.
  • 3+ years in GMP laboratory or manufacturing environment preferred or equivalent experience.
  • Experience with automated filling equipment, especially in sterile manufacturing, is a plus.

Responsibilities

  • Create and execute equipment installation IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments/equipment and facilities/utility qualifications.
  • Develop SOPs and training materials for manufacturing equipment.
  • Perform Factory Acceptance Tests for new equipment at vendor sites and monitor results.
  • ViewLinc excursions, trend data, write reports/deviations, and communicate with clients and quality teams.

Skills

GMP experience
Calibration procedures
SOP writing
Data trending

Education

Bachelor's degree or higher in science/engineering

Tools

ViewLinc
Vendor FAT

Job description

Quality Chemical Laboratories in Wilmington, NC seeks a Validation Engineer to lead equipment qualification and process validation in a GMP setting. Responsibilities include IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and facilities.

You will develop SOPs and training materials to support manufacturing operations and perform FA T at vendor sites. Experience with ViewLinc for excursions and data trending, plus strong communication with management and the

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