GMP Validation Engineer – Sterile Equipment

NCSL International; Wilmington (NC); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Validation Engineer to join the Manufacturing and Formulations Services team. The role requires a Bachelor's degree in a scientific or engineering field and hands-on GMP experience.

You will create and execute IQ/OQ/PQ activities, calibration and preventive maintenance for manufacturing equipment, develop SOPs, perform FAT at vendor sites, monitor excursions, and analyze data to support regulatory compliance and operational

Qualifikationen

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

Aufgaben

• Create and execute IQ/OQ/PQ for manufacturing instruments and equipment.
• Calibrate, qualify, and perform preventive maintenance on manufacturing systems.
• Develop and maintain SOPs and training materials for manufacturing equipment.
• Perform FAT for new equipment at vendor sites; monitor excursions.
• Analyze data, generate reports, change requests and deviations; communicate with stakeholders.

Kenntnisse

GMP experience

Validation planning

Data trending

Ausbildung

Bachelor's degree in science or engineering

Tools

ViewLinc

Jobbeschreibung

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Validation Engineer to join the Manufacturing and Formulations Services team. The role requires a Bachelor's degree in a scientific or engineering field and hands-on GMP experience.

You will create and execute IQ/OQ/PQ activities, calibration and preventive maintenance for manufacturing equipment, develop SOPs, perform FAT at vendor sites, monitor excursions, and analyze data to support regulatory compliance and operational