Validation Engineer

Quality Chemical Laboratories; Wilmington (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Quality Chemical Laboratories in Wilmington, NC, seeks a Validation Engineer to ensure equipment IQ/OQ/PQ, calibration, and preventive maintenance across manufacturing instruments and facilities. A Bachelor's degree in a scientific or engineering discipline and at least 3 years of GMP laboratory or manufacturing experience are required.

Experience with automated filling equipment in sterile manufacturing is a plus.

Qualifications

• Bachelor's degree in science or engineering required.
• 3+ years of GMP laboratory or manufacturing experience required.
• Experience with automated filling equipment in sterile manufacturing is a plus.

Responsibilities

• Create and execute IQ/OQ/PQ, calibration, and preventive maintenance for manufacturing instruments and facilities.
• Develop SOPs and training materials for manufacturing equipment.
• Perform Factory Acceptance Tests for new equipment at vendor sites.
• Monitor excursions with ViewLinc; perform data trending; write reports, change requests, and deviations; communicate with clients, manufacturing and formulations management, and quality group.

Skills

GMP experience

IQ/OQ/PQ

Calibration

Preventive maintenance

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

• 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.