Pharmaceutical Manufacturing Operator Direct experience in pharma is required, experience with inhalers, nebulizers, or similar products. 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.
- SkillsDPI manufacturing
- Dry-powder handling
- Granulation and compoundingTRV blender operation
- Mixer and compounding-system operation
- Blister filling and packaging
- Batch Record documentation
- In-process quality controlcGMP compliance
- Equipment cleaning and setup
- Environmental control awareness
- Attention to detail
- At ttg, "We believe in making a difference One Person at a Time," ttg OPT.IND3
