GMP Validation Engineer: Equipment Installations & OQ/PM

Vance Airscoop; Wilmington (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Subsidized childcare

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer with a bachelor’s degree in science or engineering and 3 years of GMP experience. Experience with automated filling equipment in a sterile manufacturing setting is highly valued.

Responsibilities include installation qualifications, OQ/RQ, calibration, preventive maintenance, SOP creation, FATs, data trending, deviations, and cross‑functional communication with clients and internal teams.

Qualifications

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

Responsibilities

• Create and execute installation qualifications and requalification testing.
• Perform operational qualification and requalification (OQ/RQ).
• Carry out calibration and preventive maintenance for manufacturing instruments and utilities.
• Develop SOPs and training materials for manufacturing equipment.
• Perform FATs for new equipment at vendor sites.
• Monitor ViewLinc and respond to excursions as needed.
• Conduct data trending, write reports, change requests and deviations, and communicate with clients and cross‑functional teams.

Skills

Validation engineering

GMP experience

Data analysis

Technical communication

Education

Bachelor’s degree in science or engineering

Tools

LabWare LIMS

ViewLinc

Factory Acceptance Tests (FAT)

Job description

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer with a bachelor’s degree in science or engineering and 3 years of GMP experience. Experience with automated filling equipment in a sterile manufacturing setting is highly valued.

Responsibilities include installation qualifications, OQ/RQ, calibration, preventive maintenance, SOP creation, FATs, data trending, deviations, and cross‑functional communication with clients and internal teams.