Production Operator I

Lupin•Coral Springs, FL, FL

About The Position

The Production Operator I performs batch manufacturing, filling, packaging, material handling, equipment setup, inspection, and cleaning activities in a cGMP production environment. The role includes working with DPI or MDI products and equipment, maintaining accurate batch and cleaning documentation, and supporting Quality Assurance and Laboratory operations as needed. The employee must follow SOPs, batch records, regulatory and company requirements, and health and safety procedures, including the use of required PPE. The position involves physical work for at least eight hours, regular exposure to production environments and refrigerated temperatures, and may require additional hours, including weekends, according to operational needs.

Requirements

High school diploma.
At least 5 years of experience and/or training, or an equivalent combination of education and experience, in a Production cGMP Environment.
Knowledge of FDA, cGMP, GDP, and SOPs related to the job requirements.
Ability to read and interpret English-language safety rules, SOPs, batch records, and cleaning procedures.
Proficiency in English to sign and complete batch record documentation, and ability to speak and understand English effectively.
Ability to add, subtract, multiply, and divide using different units of measure, including averages, whole numbers, common fractions, and decimals.
Ability to use common-sense thinking and understanding to carry out detailed written instructions.
Ability to sit, stand, walk, stoop, kneel, crouch, or crawl for at least 8 hours.
Ability to work daily in temperatures ranging from 2°C to 25°C and transport products to and from refrigerated coolers.
Ability to frequently lift and/or move up to 40 pounds.
Ability to work around moving mechanical parts and possible fumes, airborne particles, and toxic or caustic chemicals while using provided PPE.
Ability to wear a full-face respirator and/or TYVEK or TYCHEM jumpsuits during some cleaning operations, along with required eye, hearing, and other protective equipment.

Nice To Haves

Experience in batch manufacturing, filling, and packaging operations for DPI or MDI products.
Proficiency in cleaning, setting up, and operating DPI or MDI equipment, including TRV blenders, mixers and compounding systems, manufacturing vessels, filling machines, blister filling and packaging lines, and filling and final packaging line assemblies.
Understanding of blending uniformity, powder handling, and environmental controls required for DPI or MDI manufacturing.

Responsibilities

Verify dispensed raw materials and materials received from dispensing or prior processing stages for accuracy and compliance with batch records and SOPs.
Stage, assemble, and distribute components and materials required for manufacturing and packaging operations.
Perform daily equipment checks and document equipment usage in appropriate logbooks.
Carry out production tasks in accordance with Batch Records, SOPs, and cGMP requirements, and accurately document operational parameters and process steps.
Weigh and record components, in-process materials, and finished product quantities.
Perform routine in-process testing and inspections to support product quality and consistency.
Monitor production lines for accuracy, stability, conformity, and defects, and take corrective action when necessary.
Perform granulation, compounding, batch manufacturing, filling, and packaging activities using appropriate equipment.
Package finished goods, place products into shipping containers, and label shipments appropriately.
Handle and dispose of production waste according to SOPs at the completion of each batch.
Palletize and transport finished goods within the facility using carts or pallet jacks, including moving products to and from refrigerated storage areas.
Clean production areas and equipment and complete cleaning logs.
Support Quality Assurance 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, and deface and dispose of empty containers according to SOPs.
Conduct room and equipment inspections and maintain complete and accurate documentation.
Follow cGMP, regulatory, company compliance, health and safety, and business ethics requirements; use required PPE and maintain a clean, safe, and organized work environment.
Perform additional duties as assigned by Manufacturing Management.