Validation Engineer

The Charlotte Observer Publishing Company; Wilmington (NC); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits package

Career advancement opportunities

Job summary

Quality Chemical Laboratories (QCL) in Wilmington seeks a Validation Engineer to oversee installation, IQ/OQ, calibration, and preventive maintenance for manufacturing instruments and utilities. The role includes creating SOPs and training materials for manufacturing equipment and performing FATs at vendor sites.

The candidate will monitor excursions, perform data trending, and prepare reports, change requests, and deviations while liaising with clients, manufacturing and formulations

Qualifications

• Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of experience or equivalent
• Experience in GMP laboratory or manufacturing environment
• Special consideration for automated filling equipment in sterile manufacturing

Responsibilities

• Create and execute installation qualification and operational qualification
• Conduct calibration and preventive maintenance for manufacturing equipment and facilities
• Develop SOPs and training materials for manufacturing equipment
• Perform Factory Acceptance Tests at vendor sites and monitor excursions
• Conduct data trending, write reports, change requests, and deviations
• Coordinate with clients, manufacturing and formulations management, and quality groups

Skills

GMP experience

QA documentation

Sterile manufacturing

Equipment qualification

Education

Bachelor's degree

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.