Validation Engineer

Clay Today; Wilmington (NC); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career advancement

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer with a scientific or engineering background and a minimum of 3 years in GMP laboratories or manufacturing environments.

The role covers IQ/OQ/PQ for equipment, calibration, preventive maintenance, and qualifications for facilities and utilities, plus SOP creation and reporting. Experience with automated filling equipment in sterile manufacturing is a plus.

Qualifications

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

Responsibilities

• Create and execute IQ/OQ/PQ for equipment installation and operations.
• Perform calibration and preventive maintenance for manufacturing instruments and equipment.
• Develop SOPs and training materials for manufacturing equipment; conduct Factory Acceptance Tests.
• Monitor excursions, data trending, and write reports, change requests, and deviations.
• Coordinate with clients, manufacturing and formulations management, and quality group.

Skills

GMP knowledge

Communication

Education

Bachelor's degree or higher in science or engineering

Tools

ViewLinc

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.