Quality Engineer - Pharmaceutical Compounding Environment 

 

Our client, a Compounding Pharmacy has two Orlando locations: a large 503B FDA registered outsourcing facility; and a full-service 503A pharmacy for the compounding (admixture) of sterile and non-sterile specialty medications for consumers. With a positive work culture and Only Weekday hours, no weekends; the Quality Engineer will perform a variety of mechanical and pharmaceutical compliance engineering roles.

The Quality Engineer will work within the engineering department in the areas of calibration, vendor coordination, preventative maintenance, improvement projects, equipment qualification, and computer automated design. This position should provide support to technicians, staff, and infrastructure to ensure FDA compliant, timely and effective equipment and engineering practices as well as further improve efficiency in various areas.

Quality Engineer Tasks and Responsibilities
• Equipment Calibration tracking and scheduling.
• Equipment/Facility Validation planning, tracking, and scheduling.
• Vendor coordination for equipment preventative maintenance and scheduled maintenance.
• Vendor coordination for calibration services.
• Work alongside engineering and quality department to ensure project deadline readiness.
• Handle equipment repairs, service requests and address any equipment related issues.
• Utilize CAD programs to develop and implement custom design fabrications.

 

Quality Engineer desired Education and Experience
• Bachelor of Science in Mechanical Engineering or equivalent.
• 2+ years with mechanical experience or related projects.
• Excellent computer and critical thinking skills.
• Sterile Manufacturing in a pharmaceutical setting.
• Former experience with Master Control

Key Competencies
• Ability to work within a team and at a self-directive capacity.
• Excellent mechanical aptitude.
• Ability to troubleshoot, diagnose and repair mechanical and hardware related issues.
• Computer literacy.
• Project tracking and timeline skills
• Time management and punctuality