Validation Engineer: GMP Equipment Qualification & QA

Vance Airscoop; Wilmington (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to support equipment installation, qualification, calibration, and maintenance within the Manufacturing and Formulations Services department. A Bachelor’s degree in science or engineering and 3 years of GMP experience are required, with preference for automated filling equipment in sterile manufacturing.

You will develop SOPs, run FATs, monitor excursions, trend data, and prepare deviation reports while

Qualifications

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

Responsibilities

• Create and execute equipment installation and operational qualification/requalification, calibration, and preventive maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications/development.
• Develop SOPs and training materials for manufacturing equipment and processes; perform FATs at vendor sites and monitor.
• View excursions, perform data trending and write reports, change requests and deviations; communicate with clients, manufacturing and formulations management, and the quality group.

Skills

GMP compliance

Data trending

Documentation

Communication

Education

Bachelor's degree in science or engineering

Tools

ViewLinc

Job description

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to support equipment installation, qualification, calibration, and maintenance within the Manufacturing and Formulations Services department. A Bachelor’s degree in science or engineering and 3 years of GMP experience are required, with preference for automated filling equipment in sterile manufacturing.

You will develop SOPs, run FATs, monitor excursions, trend data, and prepare deviation reports while