Validation Engineer

NCSL International; Wilmington (NC); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to join the Manufacturing and Formulations Services team. A BS or higher in a scientific or engineering field plus 3 years of GMP experience is required, or an equivalent education/experience combination.

Responsibilities include creating and executing equipment IQ/OQ/PQ, calibration, and PM for manufacturing instruments; developing SOPs and training materials; performing FATs; and reviewing excursions, trends, and

Qualifications

• Bachelor's degree or higher in a scientific or engineering discipline with 3 years of GMP laboratory or manufacturing experience
• Experience in validation/qualification of equipment and facilities
• Preference for experience with automated filling equipment in sterile manufacturing environments

Responsibilities

• Create and execute equipment installation and IQ/OQ/PQ/Calibration/PM for manufacturing instruments and facilities
• Develop SOPs and training materials for manufacturing equipment
• Perform FATs for new equipment at vendor sites and monitor
• ViewLinc excursions, trend data, and write reports, change requests, and deviations; communicate with clients, manufacturing and quality teams

Education

Bachelor's degree or higher in scientific/engineering discipline

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

• 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.