Validation Engineer

NCSL International; Wilmington (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Validation Engineer to join the Manufacturing and Formulations Services team. The role requires a Bachelor's degree in a scientific or engineering field and hands-on GMP experience.

You will create and execute IQ/OQ/PQ activities, calibration and preventive maintenance for manufacturing equipment, develop SOPs, perform FAT at vendor sites, monitor excursions, and analyze data to support regulatory compliance and operational

Qualifications

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

Responsibilities

• Create and execute IQ/OQ/PQ for manufacturing instruments and equipment.
• Calibrate, qualify, and perform preventive maintenance on manufacturing systems.
• Develop and maintain SOPs and training materials for manufacturing equipment.
• Perform FAT for new equipment at vendor sites; monitor excursions.
• Analyze data, generate reports, change requests and deviations; communicate with stakeholders.

Skills

GMP experience

Validation planning

Data trending

Education

Bachelor's degree 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 manufacturing environment. 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.