Encapsulation Machine Operator II

Great HealthWorks, Inc.; Florida; On-site; USD 40,000 - 60,000; Full time

Job summary

Great HealthWorks, Inc. is seeking an Encapsulation Machine Operator II to operate encapsulation equipment and manufacture products according to batch records.

You will handle non-critical machine parts and ensure GMP compliance in a fast-paced pharmaceutical environment. Responsibilities include startups, changeovers, monitoring production, documenting batch records, and maintaining a clean, safe work area.

Qualifications

• Maintain safe work practices around production equipment.
• Adhere to SOPs for Soft Gel and Encapsulation equipment.
• Must read and follow SOPs and GMP regulations.
• Able to perform basic math calculations.
• Read, write, and speak English.
• Follow written and oral instructions.

Responsibilities

• Follow SOPs for Soft Gel and Encapsulation equipment.
• Take discrepancies to supervisor and obtain approval before operating equipment.
• Monitor machine during processing.
• Perform gelat in and fill material changeover operations.
• Troubleshoot product/equipment issues.
• Perform startups and in-process testing per batch records.
• Clean machines and production areas; manage non-critical components.
• Inspect non-critical parts for damage.
• Execute major and minor equipment changeovers with proper batch documentation.
• Obtain QA clearance for equipment and GMP rooms.

Skills

Safety awareness

Punctuality

English proficiency

Instruction following

Teamwork

Overtime flexibility

GMP knowledge

Reading SOPs

Education

High school diploma or GED

Job description

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.

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
• Monitors the machine 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
• Operate all soft gel encapsulation equipment
• 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
• Maintain a safe work environment
• Other duties as assigned

Qualifications

Education and Experience

• High school diploma or GED (General Education Diploma)
• 2 years of Soft Gel Encapsulation experience
• Able to read and follow SOPs
• Able to work in compliance with current GMPs
• Able to perform basic math calculations (add, subtract, multiply, divide)
• Able to follow written and verbal instructions

Knowledge, Skills, And Abilities

• Work safely around production equipment and in a manufacturing setting
• Arrives on or before the scheduled start time to properly review duties for the day
• Able to read, write, and speak English, plus perform basic math
• Follow both written and oral instructions
• Works well independently and with a team
• Flexibility to work different job functions and overtime
• Successfully pass pre-employment screenings, including a drug screen
• 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.