Validation Engineer

NCSL International; Wilmington, Northern (NC, KY); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Benefits package

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Validation Engineer with a Bachelor's degree or higher in a scientific or engineering discipline and at least 3 years of GMP lab or manufacturing experience.

Responsibilities include developing and executing IQ/OQ/PQ for equipment, writing SOPs and training materials, performing FATs, monitoring excursions with ViewLinc, data trending, and preparing deviation reports and change requests.

Qualifications

• Bachelor's degree or higher in a scientific or engineering discipline with 3 years of experience in a GMP laboratory or manufacturing environment.
• Special consideration given to candidates with experience with automated filling equipment in sterile manufacturing.

Responsibilities

• Create and execute IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications.
• Develop SOPs and training materials for manufacturing equipment.
• Perform Factory Acceptance Tests for new equipment at vendor sites and monitor.
• ViewLinc excursions, perform data trending, write reports, change requests, and deviations; communicate with clients and cross-functional teams.

Skills

GMP experience

Quality systems

Data trending

Education

Bachelor's degree or higher in a scientific or 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 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.