Production Operator I - GMP Manufacturing & Packaging

Lupin Ltd; Town of Florida (NY); On-site; USD 48,000 - 68,000; Full time

Job summary

Lupin Ltd in New York is seeking a GMP-focused production operator for DPI/MDI batch manufacturing, filling, and packaging. You will verify materials, stage equipment, document processes, and perform in-process testing to ensure quality, with strict adherence to SOPs and batch records.

Role requires 5+ years in production cGMP environments, ability to read English documents, and willingness to operate diverse DPI/MDI equipment. On-site facility with strict safety protocols.

Qualifications

• High school diploma required.

Responsibilities

• Verify dispensed raw materials for each batch, ensuring accuracy and compliance with batch records and SOPs.
• Stage components and assemble production equipment required for manufacturing and packaging operations.
• Perform daily equipment checks and document usage in appropriate logbooks.
• Document operational parameters and process steps within batch manufacturing records.
• Weigh and record components, in-process materials, and finished product quantities.
• Perform routine in-process testing and inspections to ensure product quality and consistency.
• Monitor production lines for accuracy, stability, conformity, and product defects; take corrective actions when necessary.
• Package finished goods, including placing products into shipping containers and labeling shipments appropriately.
• Handle and properly dispose of production waste in compliance with SOPs at the completion of each batch.
• Palletize and transport finished goods within the facility using carts or pallet jacks, including movement to and from refrigerated storage areas.
• Clean production areas and equipment, maintaining proper documentation in cleaning logs.
• Support Quality Assurance (QA) and Laboratory operations as needed.
• Maintain GMP-compliant storage, issuance, and control of tooling and materials.
• Prepare and return partial raw material containers to the warehouse; properly deface and dispose of empty containers per SOPs.
• Verify the accuracy of materials received from dispensing and prior processing stages.
• Perform granulation, compounding, batch manufacturing, filling, and packaging activities using appropriate equipment.
• Conduct room and equipment inspections and maintain complete and accurate documentation.
• Adhere to all cGMP, regulatory, and company compliance requirements.
• Follow all Health & Safety policies, procedures, and training guidelines.
• Properly use required Personal Protective Equipment (PPE) at all times.
• Maintain a clean, safe, and organized work environment.
• Operate in alignment with the company’s Code of Conduct and Business Ethics.
• Perform additional duties as assigned by Manufacturing Management.
• Experience in batch manufacturing, filling, and packaging operations for DPI or MDI products.
• Proficient in cleaning, setup, and operation of DPI or MDI related equipment, including: TRV blenders, Mixers and compounding systems, Manufacturing vessels, Filling machines
• Blister filling and packaging lines, Filling and final packaging line assemblies
• Understanding of blending uniformity, powder handling, and environmental controls required for DPI or MDI manufacturing.
• Ensures adherence to SOPs, batch records, and regulatory requirements throughout the production process.

Skills

cGMP compliance

Batch records

SOP adherence

Documentation

Quality inspection

Equipment operation

PPE usage

Safety training

Packaging operations

Education

High school diploma

Knowledge of FDA/cGMP regulations

Tools

TRV blenders

Mixers

Filling machines

Blister packaging lines

Calibration logs

Job description

Lupin Ltd in New York is seeking a GMP-focused production operator for DPI/MDI batch manufacturing, filling, and packaging. You will verify materials, stage equipment, document processes, and perform in-process testing to ensure quality, with strict adherence to SOPs and batch records.

Role requires 5+ years in production cGMP environments, ability to read English documents, and willingness to operate diverse DPI/MDI equipment. On-site facility with strict safety protocols.