Validation Engineer

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

Benefits offered by this job

Subsidized childcare

Excellent benefits package

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC, seeks a Validation Engineer with a Bachelor’s degree in a scientific or engineering discipline and at least 3 years of GMP experience. Experience with automated filling equipment in sterile manufacturing is a plus.

Responsibilities include IQ/OQ/PQ, SOP development, vendor FATs, and data trending. This role is in the Manufacturing and Formulations Services department and offers opportunities for growth in a rapidly expanding pharmaceutical

Qualifications

• Bachelor’s degree or higher in a scientific or engineering discipline with 3 years of experience in GMP lab or manufacturing.
• Experience with automated filling equipment, especially in sterile manufacturing, is a plus.
• Special consideration given to candidates with advanced degrees in chemistry or related sciences and GMP data review experience.

Responsibilities

• Create and execute IQ/OQ/IQ/R for equipment and utilities in manufacturing.
• Develop SOPs 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, write reports, change requests and deviations.
• Communicate with clients, manufacturing, formulations management and quality groups.

Skills

GMP experience

Analytical thinking

Effective communication

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 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
• 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.