Validation Engineer

Quality Chemical Laboratories; Wilmington (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

Quality Chemical Laboratories in Wilmington, NC seeks a Validation Engineer to lead equipment qualification and process validation in a GMP setting. Responsibilities include IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and facilities.

You will develop SOPs and training materials to support manufacturing operations and perform FA T at vendor sites. Experience with ViewLinc for excursions and data trending, plus strong communication with management and the

Qualifications

• Bachelor’s degree or higher in scientific or engineering discipline required.
• 3+ years in GMP laboratory or manufacturing environment preferred or equivalent experience.
• Experience with automated filling equipment, especially in sterile manufacturing, is a plus.

Responsibilities

• Create and execute equipment installation IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments/equipment and facilities/utility qualifications.
• Develop SOPs and training materials for manufacturing equipment.
• Perform Factory Acceptance Tests for new equipment at vendor sites and monitor results.
• ViewLinc excursions, trend data, write reports/deviations, and communicate with clients and quality teams.

Skills

GMP experience

Calibration procedures

SOP writing

Data trending

Education

Bachelor's degree or higher in science/engineering

Tools

ViewLinc

Vendor FAT

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.