Macdillions Global Energy LLC

Quality Engineer (Validations)– job post

Atlanta, GA 30313
Description: The Quality Engineer (Validations) for Vero Biotech is responsible for leading validation and qualification activities to ensure compliance and product quality. Incumbent possesses a solid understanding of process validation for pharma and medical devices.  
  • Leads and/or Participates in the following activities, as needed:
  • Ensure validation and qualification program maintains compliance to applicable regulations and company policies.
  • Leads, writes or coordinates protocols that challenge critical parameters related to installation, operation, and performance of the related facilities, utilities, computer systems or equipment, and assures that protocols are approved through proper processes.
  • Assists and/or coordinates investigation activities with Quality Assurance and Engineering regarding deviations, Non-conformances, CAPA, and complaints.
  • Reviews/develops Engineering test/qualification protocols, where required, to assure product/design changes are properly validated prior to release.
  • Supports the quality operations groups on inspection/training/equipment related issues.
  • Participate in risk management activities.
  • Participate in continuous improvement projects and prepare metrics/reports by collecting, analyzing, and summarizing data. Make recommendations based on data.
  • Performs process capability analysis and assists in design of experiment activities.
  • Interfaces with R&D Engineering on design and specification related issues as well as tool approvals, as required.
  • Works closely with Quality Systems/Quality Assurance personnel to assure compliance with Quality Systems requirements.
  • Engineering Degree or related field.
  • Two (2) years’ experience in pharma or medical device Quality Engineering/Validation
  • ASQ Certification preferred.
  • Knowledge of quality engineering principles
  • Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
  • Thorough knowledge of GMP, CFR, and factors impacting compliance.
  • Excellent verbal and written communications skills in English
  • Acute attention to detail
  • Demonstrated ability to plan and organize projects
  • Ability to work independently and as member of various teams and committees
  • Working knowledge of data collection, data analysis, evaluation, and scientific method.