Pharmaceutical Machine Operator

Cynet Systems•Davie, FL

14h

About The Position

The Machine Operator sets up and operates manufacturing equipment for processing operations, performs material blending and granulation, maintains processing rooms and equipment, and ensures compliance with batch records, standard operating procedures, and applicable organizational policies and laws. The role monitors processes, equipment, and product quality; makes adjustments to maintain batch record specifications; conducts in-process testing; performs calculations and reconciliations; and keeps manufacturing records current. Work takes place in a manufacturing environment where noise levels range from moderate to loud depending on machinery use. The work may require respirator use, subject to a Pulmonary Function Test to determine eligibility for fit-testing. The role requires climbing a ladder or using a lift up to 15 feet for cleaning and setup procedures approximately two to three times per week, as well as regular sitting, standing, walking, stooping, reaching, and climbing. The position requires lifting 35 pounds or more.

Requirements

High school diploma or equivalent.
Warehouse or manufacturing experience.
Experience blending materials and working with granulations.
Experience with granulation, compression, milling, blending, and related manufacturing processes.
Strong attention to detail when verifying materials, labels, and batch numbers.
Strong technical aptitude and ability to learn and operate manufacturing equipment.
Willingness to perform major equipment and area cleaning, including work involving water and wet environments.
Stable employment history, including at least one year in the most recent position.
Knowledge of Current Good Manufacturing Practices (cGMP), FDA, and other regulatory requirements.
Strong verbal and written communication skills.
Basic math skills.
Ability to climb a ladder or use a lift up to 15 feet.
Ability to sit, stand, walk, stoop, reach, and climb for regular periods.
Ability to lift 35 pounds or more.
Ability to meet respirator fit-testing eligibility requirements, as determined by a Pulmonary Function Test, if respirator use is required.

Nice To Haves

Zero to one year of work experience in a manufacturing environment is preferred.

Responsibilities

Set up and operate equipment for processing operations.
Perform material blending and granulation.
Monitor processes and equipment and make adjustments to maintain batch record specifications.
Monitor product quality and conduct in-process testing.
Maintain batch records, equipment log books, and other relevant records; record manufacturing process data and perform batch record reconciliation.
Perform reconciliations and check and adjust calculations.
Check and review labels and batch records for accuracy.
Clean and maintain processing rooms and equipment, including major equipment and area cleaning.
Report process or equipment problems to a supervisor and perform basic troubleshooting.
Communicate effectively with previous and incoming shift operators and related personnel.
Follow department SOPs, batch record instructions, organization policies, safety rules, and applicable laws and regulations.
Suggest improvements to methods or processes.
Support delivery and on-time production.
Perform related duties as assigned.