Validation Engineer

Vance Airscoop; Wilmington (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Subsidized childcare

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Validation Engineer with a bachelor’s degree in science or engineering and 3 years of GMP experience. Experience with automated filling equipment in a sterile manufacturing setting is highly valued.

Responsibilities include installation qualifications, OQ/RQ, calibration, preventive maintenance, SOP creation, FATs, data trending, deviations, and cross‑functional communication with clients and internal teams.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline is required.
• 3 years of experience in a GMP laboratory or manufacturing environment, or an equivalent education/experience combination.
• Experience with automated filling equipment in sterile manufacturing is highly valued.

Responsibilities

• Create and execute installation qualifications and requalification testing.
• Perform operational qualification and requalification (OQ/RQ).
• Carry out calibration and preventive maintenance for manufacturing instruments and utilities.
• Develop SOPs and training materials for manufacturing equipment.
• Perform FATs for new equipment at vendor sites.
• Monitor ViewLinc and respond to excursions as needed.
• Conduct data trending, write reports, change requests and deviations, and communicate with clients and cross‑functional teams.

Skills

Validation engineering

GMP experience

Data analysis

Technical communication

Education

Bachelor’s degree in science or engineering

Tools

LabWare LIMS

ViewLinc

Factory Acceptance Tests (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
• operational qualification/requalification
• calibration
• preventative maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications
• develop 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

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control,Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.

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.

We now also offer subsidized childcare at our newly acquired childcare facility.

QCL is an equal opportunity employer.