Validation Engineer – GMP Pharma (Sterile) Growth

NCSL International; Wilmington (NC); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to join the Manufacturing and Formulations Services team. A BS or higher in a scientific or engineering field plus 3 years of GMP experience is required, or an equivalent education/experience combination.

Responsibilities include creating and executing equipment IQ/OQ/PQ, calibration, and PM for manufacturing instruments; developing SOPs and training materials; performing FATs; and reviewing excursions, trends, and

Qualifications

• Bachelor's degree or higher in a scientific or engineering discipline with 3 years of GMP laboratory or manufacturing experience
• Experience in validation/qualification of equipment and facilities
• Preference for experience with automated filling equipment in sterile manufacturing environments

Responsibilities

• Create and execute equipment installation and IQ/OQ/PQ/Calibration/PM for manufacturing instruments and facilities
• Develop SOPs and training materials for manufacturing equipment
• Perform FATs for new equipment at vendor sites and monitor
• ViewLinc excursions, trend data, and write reports, change requests, and deviations; communicate with clients, manufacturing and quality teams

Education

Bachelor's degree or higher in scientific/engineering discipline

Tools

ViewLinc

Job description

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to join the Manufacturing and Formulations Services team. A BS or higher in a scientific or engineering field plus 3 years of GMP experience is required, or an equivalent education/experience combination.

Responsibilities include creating and executing equipment IQ/OQ/PQ, calibration, and PM for manufacturing instruments; developing SOPs and training materials; performing FATs; and reviewing excursions, trends, and