Sterile Fill Production Machine Operator; Midnights

Overview

Sterile Fill Production Machine Operator (Midnights) s role involves operating and maintaining production equipment in a sterile filling environment in accordance with applicable GMP/GLP standards.

• Sets up, checks, adjusts and runs production equipment as required by product and size change over.
• Communicates effectively and in a timely manner with fill and seal operators and Area Supervisors to ensure an efficient filling operation.
• Coordinates with Area Supervisors to maintain an efficient filling operation and communicates with the Supervisor regarding line conditions, product quality, and potential improvements.
• Cleans, lubricates, starts, stops, and services equipment to promote smooth and efficient production flow.
• Performs environmental and personnel monitoring sampling and recording when required.
• Ensures correct and adequate labels, materials, and supplies are provided to meet production schedules and maintains continuous material supply to production lines.
• Notifies Area Supervisor of processes or equipment not in regulatory compliance when discovered.
• Total time allocations include: operational 70%, documentation 10%, compliance 10%, testing 10%.

• High School Diploma, GED or equivalent.
• Successful completion of in-house training programs (includes Upgrader Exam).
• Proficiency in required knowledge areas such as FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Arithmetic aptitude and aptitude for pressure and temperature-related tasks are preferred.
• Mechanical aptitude and ability to use hand tools and measuring instruments are preferred.
• Physical requirements include ability to reach with hands and arms, lift up to 50 pounds, and perceive close vision; work in a production/manufacturing environment with exposure to moving parts and chemicals.

Endo is committed to a diverse, equitable and inclusive workplace. We are an equal employment opportunity employer and make employment decisions based on qualifications, skills and merit without regard to race, color, religion, sex, gender identity or expression, national origin, genetics, disability status, age, or military/veteran status.