Press Operator Tablet Capsule

Position Summary

The Press Operator is responsible for operating tablet compression presses and capsule filling machines to produce finished dietary supplement tablets and capsules from blended powder formulations. This role requires technical skill in machine setup, adjustment, and operation, as well as rigorous adherence to FDA cGMP regulations under 21 CFR Part 111. The Press Operator performs critical in‑process quality checks and maintains detailed batch production records to ensure that every tablet and capsule meets specifications for weight, hardness, friability, disintegration, and fill accuracy.

• Set up, operate, and adjust rotary and/or single‑punch tablet presses per master batch records and SOPs.
• Install and align tooling (punches and dies) for tablet compression, ensuring correct tablet shape, size, and embossing per product specifications.
• Load blended granulation/powder into press hoppers and monitor material feed throughout production runs.
• Monitor and adjust compression force, pre‑compression force, tablet weight, hardness, and thickness parameters to maintain in‑specification production.
• Perform and document in‑process quality checks at required intervals, including individual tablet weight, hardness (kp), friability, thickness, and visual appearance.
• Identify and segregate out‑of‑specification tablets, document deviations, and notify the Production Manager and Quality Department.

• Set up, operate, and adjust automatic or semi‑automatic capsule filling machines per master batch records and SOPs.
• Select and load correct capsule shells (size, color, material) per product specifications.
• Load blended powder into capsule filling machine hoppers and monitor fill consistency.
• Monitor and adjust fill weight, capsule closure, and reject mechanisms throughout production runs.
• Perform and document in‑process checks including individual capsule fill weight, weight variation, capsule closure integrity, and visual appearance.
• Perform capsule polishing/dedusting operations as required.

• Perform complete machine changeovers between product runs, including disassembly, cleaning, sanitizing, and reassembly of all product‑contact parts.
• Complete line clearance procedures and documentation before beginning a new product run.
• Perform routine preventive maintenance on presses and capsule machines (lubrication, inspection of wear parts, tooling inspection).
• Maintain tooling inventory and report worn, chipped, or damaged punches and dies for replacement.
• Follow lockout/tagout (LOTO) procedures for all maintenance and cleaning activities.

• Complete batch production records accurately, legibly, contemporaneously, and in permanent ink for all tablet and capsule production activities.
• Record all machine parameters, in‑process test results, yields, and reconciliation data as specified in the batch record.
• Document any deviations, equipment malfunctions, or out‑of‑specification results and report to the Production Manager and Quality Department immediately.
• Maintain equipment logbooks recording usage, cleaning, and maintenance activities.

• Wear all required PPE including dust mask or N95 respirator, safety glasses, nitrile gloves, hairnet, lab coat, and hearing protection (as required).
• Follow dust control and housekeeping procedures to prevent combustible dust accumulation around presses.
• Follow all Haz Com and chemical safety procedures.
• Report any injuries, near‑misses, or safety concerns immediately.

• High school diploma or GED equivalent.
• Minimum 2 years of experience operating tablet presses and/or capsule filling machines in a pharmaceutical, nutraceutical, or dietary supplement manufacturing environment.
• Demonstrated knowledge of tablet compression parameters (hardness, friability, weight, thickness) and capsule fill weight control.
• Experience with cGMP documentation including batch production records and equipment logbooks.
• Mechanical aptitude for machine setup, tooling installation, adjustment, troubleshooting, and basic preventive maintenance.
• Ability to use precision measurement instruments…