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.