Validation Engineer

Clay Today; Wilmington, Northern (NC, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer to execute IQ/OQ/PQ, calibrations, and qualifications for manufacturing instruments, equipment, facilities and utilities.

Candidates should hold a Bachelor’s degree in a scientific or engineering discipline with 3 years of GMP laboratory or manufacturing experience; experience with ViewLinc is a plus.

Join a growing team with strong growth potential and competitive benefits.

Qualifications

• Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of GMP lab or manufacturing experience.
• Experience with automated filling equipment is a plus.
• Strong documentation and QA/reporting skills are required.

Responsibilities

• Create and execute installation/operational qualification and requalification for manufacturing instruments and equipment, plus facilities/utilities qualifications.
• Develop and maintain SOPs and training materials for manufacturing equipment.
• Perform Factory Acceptance Tests for new equipment at vendor sites; monitor/installations.
• ViewLinc excursions handling, data trending, and write reports and deviation/change requests; communicate with clients and QA.

Skills

GMP experience

Validation

Equipment qualifications

ViewLinc

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 manufacturingenvironment. 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.