Production Operator I

About the role

The Production Operator I is responsible for executing batch manufacturing, filling, and packaging activities in a cGMP environment. You will work on DPI/MDI products, ensuring that all processes follow SOPs, batch records, and regulatory standards.

Key responsibilities

• Verify raw material dispensing and stage components for each batch.
• Perform daily equipment checks, document usage, and operate TRV blenders, mixers, compounding systems, manufacturing vessels, and filling machines.
• Document operational parameters, weigh components, and record in‑process and finished‑product quantities.
• Conduct routine in‑process testing, monitor production lines for defects, and take corrective actions.
• Package finished goods, label shipments, palletize, and transport items within the facility.
• Maintain clean production areas, complete cleaning logs, and support QA and laboratory operations.
• Handle waste disposal, manage tooling and material storage, and ensure compliance with health, safety, and PPE requirements.

Required profile

• Experience in batch manufacturing, filling, and packaging of DPI or MDI products.
• Proficiency with cleaning, setup, and operation of DPI/MDI equipment such as TRV blenders, mixers, compounding systems, and filling lines.
• Understanding of blending uniformity, powder handling, and environmental controls.
• Commitment to adhering to SOPs, batch records, and regulatory requirements.

Required skills

• TRV blenders
• Mixers and compounding systems
• Manufacturing vessels
• Filling machines
• Blister filling and packaging lines
• Final packaging line assemblies
• cGMP compliance
• SOP and batch record documentation
• Equipment inspection and cleaning log maintenance
• PPE usage and health‑safety procedures