Production DPI Operator - 2nd Shift

Overtime and weekend work may occasionally be required.

Type of

Contract:

Temp to perm

Pay Rate: $22/h - $25/h

Description

The Production DPI Operator is responsible for manufacturing Dry Powder Inhaler products in a regulated pharmaceutical production environment. This position performs general production activities while specializing in powder handling, blending, granulation, filling, and packaging processes associated with DPI products.

The role requires hands-on experience operating and cleaning specialized DPI manufacturing equipment while maintaining strict compliance with Batch Records, SOPs, cGMP requirements, quality standards, and environmental controls.

Responsibilities and Duties

• Verify raw materials dispensed for each DPI manufacturing batch.
• Stage materials, components, and specialized production equipment.
• Set up, clean, and operate DPI-related manufacturing equipment.
• Operate TRV blenders, mixers, and compounding systems.
• Operate blister filling, packaging, and final assembly lines.
• Perform granulation, compounding, filling, batch manufacturing, and packaging activities.
• Monitor blending uniformity and powder-handling processes.
• Maintain environmental controls required for DPI manufacturing.
• Perform daily equipment inspections and complete equipment logbooks.
• Document operating parameters and production steps in Batch Records.
• Weigh and record materials and finished product quantities.
• Conduct in-process testing and product inspections.
• Monitor production lines for quality, consistency, and defects.
• Package, label, palletize, and transport finished products.
• Clean production rooms and manufacturing equipment.
• Complete cleaning, sanitation, and equipment documentation.
• Dispose of production waste according to SOPs.
• Support QA and Laboratory activities when required.
• Follow all cGMP, regulatory, health, and safety requirements.
• Use required PPE and maintain a clean and organized production area.

Requirements

• High school diploma.
• Minimum of five years of experience or training in a cGMP production environment, or an equivalent combination of education and experience.
• Experience in batch manufacturing, filling, and packaging of DPI products.
• Experience cleaning, setting up, and operating DPI manufacturing equipment.
• Knowledge of FDA requirements, cGMP, GDP, SOPs, and Batch Records.
• Understanding of powder handling, blending uniformity, and environmental controls.
• Ability to read, write, and communicate effectively in English.
• Ability to complete production and batch documentation accurately.
• Ability to perform basic mathematical calculations.
• Ability to follow detailed written procedures.
• Ability to lift and move up to 50 pounds.
• Ability to work in temperatures ranging from approximately 2°C to 25°C.
• Ability to wear respirators, protective suits, eye protection, hearing protection, and other required PPE.
• Ability to work overtime or weekends when operationally necessary.

Skills

• DPI manufacturing
• Granulation and compounding
• Mixer and compounding-system operation
• Blister filling and packaging
• Batch Record documentation
• In-process quality control
• cGMP compliance
• Equipment cleaning and setup
• Environmental control awareness

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