Validation Engineer

The Charlotte Observer Publishing Company; Wilmington, Northern (NC, KY); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington seeks a Validation Engineer with a scientific or engineering degree and GMP experience. The role focuses on IQ/OQ/PQ, calibration, and maintenance of manufacturing equipment within the Manufacturing and Formulations Services department.

Responsibilities include SOP development, equipment qualification, and handling excursions with data trending, reports, and coordination with QA and clients.

Qualifications

• Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of GMP lab/manufacturing experience.
• Experience with automated filling equipment in sterile manufacturing is preferred.

Responsibilities

• Create and execute equipment IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and equipment.
• Develop SOPs and training materials for manufacturing equipment.
• Factory Acceptance Tests at vendor sites; monitor.
• ViewLinc and respond to excursions; perform data trending and write reports, change requests, and deviations; communicate with clients, manufacturing and formulations management, and QA.

Skills

GMP experience

Validation expertise

Equipment calibration

Data trending

Education

Bachelor’s degree in a scientific or engineering discipline

Tools

ViewLinc

Calibration tools

Job description

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This position, in the Manufacturing and Formulations Services department, requires a Bachelor’s degree or higher in a scientific or engineering discipline with either 3 years of experience or an equivalent combination of education and experience in a GMP laboratory or manufacturingenvironment. Special consideration given to candidates with experience with automated filling equipment especially in a sterile manufacturing environment.

Responsibilities include:Create and execute equipment installation and operational qualification/requalification, calibration, and preventative maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications /development. Standard Operating Procedures and training materials for manufacturing equipment / perform. Factory Acceptance Tests for new equipment at vendor sites/monitor. ViewLinc and respond to excursions as needed/perform data trending and write reports, change requests, and deviations / communicate with clients, manufacturing and formulations management, and the quality group.

QCL offers competitive salaries commensurate with experience and an excellent benefits package as well as great potential for career advancement and leadership in a rapidly growing company.