GMP Compliance Engineer

2 weeks ago


Wilmington, North Carolina, United States Quality Chemical Laboratories Full time


Quality Chemical Laboratories (QCL) is a prominent player in the Pharmaceutical testing and manufacturing sector, currently in search of a skilled individual for the role of Validation Engineer.

This role, situated within the Manufacturing and Formulations Services division, mandates a Bachelor’s degree or higher in a scientific or engineering field, accompanied by a minimum of 3 years of relevant experience or a comparable mix of education and experience in a GMP laboratory or manufacturing setting. Candidates with a background in automated filling systems, particularly in sterile production environments, will be given special consideration.



Key Responsibilities:
  • Develop and implement equipment installation and operational qualification/requalification, calibration, and preventive maintenance protocols for manufacturing instruments and equipment.
  • Oversee facilities and utilities qualifications and development.
  • Create Standard Operating Procedures and training documentation for manufacturing equipment.
  • Conduct Factory Acceptance Tests for new equipment at vendor locations and provide oversight.
  • Utilize ViewLinc to monitor excursions and perform data trending.
  • Prepare reports, change requests, and deviations as necessary.
  • Facilitate communication with clients, manufacturing and formulations management, and the quality assurance team.

QCL provides competitive compensation aligned with experience, along with a comprehensive benefits package and significant opportunities for career growth and leadership within a rapidly expanding organization.



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