Encapsulation Machine Operator

Position Summary

The Encapsulation Machine Operator sets up, operates, and maintains automatic and semi-automatic encapsulation equipment to produce hard-shell (and/or softgel) capsules for dietary supplements and nutraceutical products. The role ensures that all products meet specifications for weight, quality, and safety in compliance with current Good Manufacturing Practices (cGMP), company Standard Operating Procedures (SOPs), and applicable regulations (e.g., FDA 21 CFR Part 111, Health Canada NNHPD requirements).

Key Responsibilities

Machine Operation and Setup

• Set up, operate, and adjust encapsulation machines (e.g., Bosch GKF, IMA, MG2, Capsugel, or semi-automatic fillers) according to batch records and SOPs.
• Perform changeovers, including installing and removing change parts (dosing discs, tamping pins, segments) for different capsule sizes (#000 to #4).
• Load empty capsules and powder or granule blends into the machine, making sure the correct materials are used for each batch.
• Monitor machine speed, fill weight, and output throughout the run, adjusting settings as needed to stay within specification.

Quality Control and In-Process Checks

• Perform in-process checks at required intervals, such as capsule weight (individual and average), weight variation, visual inspection for defects (dents, splits, unlocked caps, leaking powder), and lock length.
• Record all results accurately in the batch production record and logbooks, following Good Documentation Practices (GDP).
• Identify, segregate, and report non-conforming product, and alert the supervisor and QA to deviations.
• Operate auxiliary equipment such as capsule polishers, deduster, metal detectors, and capsule sorters.

Cleaning and Maintenance

• Perform line clearance before and after each batch to prevent mix-ups and cross-contamination.
• Disassemble, clean, sanitize, and reassemble equipment according to cleaning SOPs, and complete cleaning logs.
• Carry out routine preventive maintenance and minor troubleshooting, and report mechanical issues to the maintenance team.

Compliance and Safety

• Follow all cGMP, SOPs, safety, and hygiene requirements, including proper gowning and PPE.
• Handle raw materials and allergens according to company procedures.
• Keep the production area clean, organized, and audit-ready.
• Take part in internal and external audits, investigations, and continuous improvement activities.

Teamwork and Communication

• Coordinate with blending, packaging, QA, and warehouse teams to keep production flowing smoothly.
• Communicate batch status, issues, and machine performance at shift handovers.
• Train and support new or junior operators as needed.

Qualifications

Education

• High school diploma or equivalent required.
• Post-secondary certificate or diploma in manufacturing, pharmaceutical technology, or a related field is an asset.

Experience

• 1–3 years of experience operating encapsulation, tablet press, or similar production equipment in a nutraceutical, pharmaceutical, or food manufacturing environment.
• Experience in a cGMP-regulated facility is strongly preferred.

Skills and Competencies

• Mechanical aptitude and the ability to troubleshoot equipment.
• Strong attention to detail and accuracy in documentation.
• Basic math skills for weight calculations and averages.
• Ability to read and follow batch records, SOPs, and work instructions.
• Good communication skills and the ability to work well in a team.
• Basic computer skills (ERP or MES systems are an asset).

Physical Requirements and Working Conditions

• Ability to stand for long periods and to lift up to 25 kg (55 lbs).
• Ability to wear PPE for extended periods, including hairnets, gloves, masks, gowns, and safety shoes.
• Work in a production environment with exposure to powders, noise, and moving machinery.
• Flexibility to work rotating shifts, overtime, or weekends as production demands.

Salary is negotiable

Pay: From $30.00 per hour

Benefits:

• Dental care
• Extended health care
• Life insurance
• Paid time off
• Vision care

Work Location: In person