Encapsulation Machine Operator II

• 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

• 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

• 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.