DPI Manufacturing Operator

2 weeks ago

Hauppauge, United States TheWiseSeeker Full time

At The Wise Seeker we are looking for a DPI Manufacturing Operator to our client: global pharmaceutical company, dedicated to high-quality, branded, and generic medicines.

Location: Central Islip, Hauppauge , New York, USA

Sector: Industrial

Tasks

The DPI Manufacturing Operator will be responsible for performing the following:

� Must be experienced in granulation process and spray jet drying (FBD Dryer).

� Perform granulation equipment transfer: Perform the loading and unloading of granulation equipment.

� Lift heavy weights: Lift heavy weights and apply ergonomic lifting techniques to avoid damaging the body.

� Oversee granulation operations: Oversee the operations performed within the granulation process, to detect any deviations or problems, ensuring the quality standards are kept.

� Perform powdered ingredients blending adding the correct binding ingredient according to the formula.

� Monitor powdered ingredients: Monitor the batch and the ingredients, ensuring the weights and measures are conforming to the specified formula.

� Maintain manufacturing rooms: Maintain the cleanliness of rooms when the manufacturing process is finished, and the product is completed according to Standard Operating Procedures (SOP).

� Mixing and granulation of powdered ingredients using mixing and milling machines to prepare the ingredients.

� cGMP/Documentation: Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP).

� Accurately and legibly document in Standard Operating Instruction (SOI) and Logbook.

� Determine when to stop a line related to a safety or quality.

� Raw Materials and Equipment Checklist Successfully Completed

� Obtain and weigh in products for all shifts.

� Moves raw materials and product to/from vault, cage, process, or storage areas.

� Inspects machine parts for unusual wear and proper lubrication.

� Operates equipment required in the manufacture of pharmaceutical products.

� Performs/reviews quality checks on weight, thickness, hardness, and friability of Product at various stages of the process according to manufacturing instructions and SOPs.

� Submits product samples to quality laboratories as required.

� Maintains product batch, room activity, and equipment records.

� Assist in running validation batches.

� Monitors the production process, makes periodic checks, and adjusts equipment or work practices to maximize production efficiency, yields, quality, and safety.

Accurately reports production and ensures reports are completed as required.

� Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up.

� Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production.

� Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns.

� Perform line cleaning.

� Segregate waste product and materials.

� Return unused material/product.

� Disassembles, cleans, and reassembles basic line equipment according to SOPs. Ensures proper inspections are conducted prior to reassembly.

� Participate in safety related programs and or safety teams as needed.

� Enforce and follow safety regulations and ensure working area is clean.

� Adhere to CIPLA’s Safety, Health, and Environmental policies.

� Other duties assigned as required by Manufacturing Management.

Requirements
  • Experience (Min 2 years) working in a Pharma or Nutraceutical unit as a Manufacturing Operator supporting Granulation, Blending, Compression, Coating, and Encapsulation.
  • Must have a work permit within the area
  • Knowledge of current Good Manufacturing Practices (cGMP), Standard Operating Procedures and Food and Drug Administration (FDA) regulations
  • Ability to communicate effectively and clearly, both written and verbally in English
  • Comply with safety and quality regulatory standards.
  • Ensure products are Manufacture in accordance with CIPLA/InvaGen standards

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