Press Operator

Job Description

Job Description

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.

Essential Duties and Responsibilities

Tablet Press Operations

• 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.

Capsule Filling Operations

• 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.

Changeover, Cleaning, and Maintenance

• 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.

cGMP Documentation

• 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.

Safety

• 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 HazCom and chemical safety procedures.

• Report any injuries, near-misses, or safety concerns immediately.

Qualifications - Required

• 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 (hardness tester, analytical balance, calipers, friability tester).

• Strong attention to detail and ability to identify visual defects.

• Ability to stand for extended periods, lift up to 50 lbs, and perform repetitive motions.

• Must pass a pre-employment drug test and be subject to random, post-incident, and reasonable suspicion testing.

Qualifications - Preferred

• Experience with multiple press types (rotary single-sided, rotary double-sided, single-punch).

• Experience with multiple capsule machine types (automatic, semi-automatic; various sizes).

Familiarity with 21 CFR Part 111 and FDA inspection readiness.

• Experience with tablet coating equipment is a plus.

• Bilingual (English/Spanish) is a plus.

Physical Requirements and Working Conditions

• Standing, walking, bending, reaching, and heavy lifting (up to 50 lbs) throughout the shift.

• Exposure to fine powder dust from tablet compression and capsule filling — respiratory protection required and provided.

• Exposure to manufacturing noise levels — hearing protection may be required.

• Repetitive hand motions for tooling installation and in-process testing.

• Work in temperature-controlled manufacturing environment.

• Must be medically cleared and fit-tested for respirator use.

Equal Opportunity Employer

MKRS is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by federal, state, or local law.