Validation Engineer

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

Benefits offered by this job

Competitive salaries

Excellent benefits

Career advancement opportunities

Job summary

Quality Chemical Laboratories in Wilmington, NC, is seeking a Validation Engineer to ensure equipment qualification and compliance in GMP manufacturing environments. The role requires a Bachelor’s degree in a scientific or engineering discipline and 3 years of related experience; experience with automated filling equipment and sterile manufacturing is a plus.

You will write SOPs, perform IQ/OQ/PQ, and support deviations and excursions.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 3 years of experience or equivalent education/experience in GMP lab or manufacturing.

Responsibilities

• Create and execute equipment installation and qualification/requalification, 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 and monitor.
• ViewLinc excursions, trend data, write reports, change requests, deviations, and communicate with stakeholders.

Skills

Calibration

IQ/OQ/PQ

GMP

Data trending

Education

Bachelor's degree in science/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 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.

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