Role Summary
The Encapsulation Operator is responsible for the daily operation of two-piece hard capsule encapsulation equipment. This position ensures the line runs efficiently, safely, and in compliance with cGMP, FDA 21 CFR Part 111, and internal quality standards. The Encapsulation Operator sets up and runs the encapsulator, monitors in-process capsule attributes (weight, lock, seal), and partners with Quality on in-process checks.
Responsibilities
- Set up, start up, operate, and clean down tamping-pin or dosator-style encapsulators (e.g., Syntegon/Bosch, IMA/Zanasi, MG2 or equivalent).
- Perform in-process capsule checks - target fill weight, weight variation, capsule lock and seal integrity, visual defect inspection.
- Change over dosing discs, tamping pins, and capsule sizes between runs.
- Follow master batch records exactly, document all in-process checks and deviations.
- Troubleshoot machine-side issues - weight variation, breakage, sticking, powder bridging - and escalate as needed.
- Perform routine machine maintenance and cleaning between batches.
- Maintain all logbooks (cleaning, calibration, scales).
- Ensure cleanliness and sanitation of equipment and encapsulation area in compliance with cGMP and FDA standards.
- Report any deviations, non-conformities, or safety concerns promptly.
- Perform all other duties as assigned by management.
Education & Experience
- High school diploma or GED required.
- 1–3 years of experience in dietary supplement, nutraceutical, or pharmaceutical manufacturing. Prior encapsulation experience strongly preferred.
Skills & Abilities
- Mechanically inclined with ability to perform minor troubleshooting.
- Comfort reading master batch records and following specific procedures.
- Ability to read, write, and perform basic math operations.
- Bilingual (English/Spanish) a plus.
- Strong knowledge of cGMP, FDA, and SOP compliance requirements.
Physical Requirements
- Ability to lift up to 50 lbs.
- Standing for extended periods.