Validation Engineer – GMP Equipment & Utilities

The Charlotte Observer Publishing Company

Wilmington (NC)

Hybrid

USD 85,000 - 120,000

Full time

11 days ago

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Benefits offered by this job

Competitive salary

Excellent benefits package

Career advancement opportunities

Job summary

Quality Chemical Laboratories (QCL) in Wilmington seeks a Validation Engineer to oversee installation, IQ/OQ, calibration, and preventive maintenance for manufacturing instruments and utilities. The role includes creating SOPs and training materials for manufacturing equipment and performing FATs at vendor sites.

The candidate will monitor excursions, perform data trending, and prepare reports, change requests, and deviations while liaising with clients, manufacturing and formulations

Qualifications

Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of experience or equivalent
Experience in GMP laboratory or manufacturing environment
Special consideration for automated filling equipment in sterile manufacturing

Responsibilities

Create and execute installation qualification and operational qualification
Conduct calibration and preventive maintenance for manufacturing equipment and facilities
Develop SOPs and training materials for manufacturing equipment
Perform Factory Acceptance Tests at vendor sites and monitor excursions
Conduct data trending, write reports, change requests, and deviations
Coordinate with clients, manufacturing and formulations management, and quality groups

Skills

GMP experience

QA documentation

Sterile manufacturing

Equipment qualification

Education

Bachelor's degree

Tools

ViewLinc

Job description

The candidate will monitor excursions, perform data trending, and prepare reports, change requests, and deviations while liaising with clients, manufacturing and formulations

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