Encapsulation Machine Operator II

Great HealthWorks, Inc.; Florida; On-site; USD 42,000 - 64,000; Full time

Job summary

NexCaps Production is seeking an Encapsulation Machine Operator II for its Riviera Beach site. The role focuses on operating encapsulation equipment and manufacturing products per batch records, while handling non-critical machine parts and ensuring quality.

The successful candidate will follow SOPs, monitor machines, perform changeovers, assist with in-process testing, and maintain clean, compliant work areas in a GMP environment.

Qualifications

• High school diploma or GED required.
• At least 2 years of Soft Gel encapsulation experience.
• Able to read and follow SOPs.
• Must work in compliance with current GMPs.
• Able to perform basic math calculations (add, subtract, multiply, divide).
• Able to follow written and verbal instructions.

Responsibilities

• Follow SOPs for Soft Gel and encapsulation equipment.
• Report discrepancies to supervisor before operating equipment.
• Monitor the machine during processing.
• Perform gelatine and fill material changeovers.
• Troubleshoot equipment and product issues.
• Perform startups and in-process testing per batch records.
• Clean machines and production areas; manage non-critical parts.
• Inspect parts for damage or wear; ensure documentation on batch records.
• Handle major and minor changeovers and proper documentation.
• Obtain QA clearance for equipment and GMP rooms.

Skills

SOP reading

GMP compliance

Basic math

Follow written instructions

English literacy

Education

High school diploma or GED

2 years Soft Gel encapsulation experience

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Encapsulation Machine Operator II

NexCaps Production Full Time Riviera Beach, US

Summary

The Encapsulation Machine Operator II performs operations on encapsulation machines and is responsible for the manufacturing of products according to Batch Records. Handles all non-critical machine component parts.

Key Responsibilities

• Follow the Standard Operating Procedures (SOPs) relating to Soft Gel and Encapsulation equipment
• Immediately bring any discrepancy to the attention of a supervisor, and obtain approval from the supervisor before operating Encapsulation equipment
• Monitorsthemachine during processing
• Performs Gelatin and Fill Material changeover operations
• Troubleshoots and identifies issues with the product and or equipment
• Perform startups and in-process testing according to batch records
• Cleans Machines, production rooms, and non-critical component parts for machines, gel boxes, medicine hopper, transfer conveyors, and tumble-drying baskets, and performs installation
• Inspects non-critical component machine parts for damage that may cause quality issues with products
• Performs major and minor changeovers of equipment and rooms efficiently and in a timely manner, along with filling out proper documentation on batch records, maintaining good documentation practices
• Gets clearance from QA on appropriate equipment and GMP rooms for processing
• Responsible for following current Good Manufacturing Practices {cGMPs), 21 CFR Part 211and 21 CFR Part 111
• Understanding of Equipment SOPs
• Good documentation practices
• Good knowledge of troubleshooting skills
• Disassemble all non-critical component equipment parts
• Assemble and install all non-critical component equipment parts
• Clean all non-critical component equipment parts
• Inspect all non-critical component parts for damage or wear
• Maintain neat and clean work areas
• Maintaina safe work environment
• Other duties as assigned

Qualifications

Education and Experience

• Highschooldiplomaor GED(GeneralEducation Diploma)
• 2 yearsofSoft Gel Encapsulation experience
• Able toread andfollowSOPs
• Able toworkincompliance with current GMPs
• Ableto perform basic mathcalculations (add, subtract,multiply, divide)
• Able to follow written and verbal instructions

Knowledge, Skills, and Abilities

• Worksafely around production equipment andina manufacturingsetting
• Arrives on orbefore the scheduled start timeto properlyreviewdutiesfor theday
• Able toread,write, and speak English,plus perform basicmath
• Followboth written and oralinstructions
• Works wellindependently and witha team
• Flexibilitytoworkdifferentjob functions and overtime
• Successfully passpre-employmentscreenings, including adrugscreen
• Knowledge and understanding of GMPs and Pharmaceutical manufacturing plant

Physical/ Work Environment/ Expectations

• Travel may be required for this position.
• This position works within an GMP Manufacturing Environment, office environment and inside the plant.
• The incumbent may be required to sit for long periods of time while performing work on a computer at a desk. Use of standard office equipment is required. While inside the plant, may be exposed to loud noises coming from equipment; may be exposed to hazardous chemicals which require the use of eye protection, and other PE depending on area within the plant.

Note: This job description is not totally inclusive, nor is it designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.