Softgel Operator II

Amneal

2d • Onsite

About The Position

The Softgel Operator II is responsible for documenting production activities, maintaining and monitoring the complete operation of softgel encapsulation machines, and ensuring adherence to cGMP and compliance standards. This role involves performing in-process checks, maintaining area cleanliness, proper use of PPE, and monitoring environmental conditions. The operator must run the encapsulation machine according to specifications, maintain equipment, and assist in the manufacturing of gelatin and fill materials. Additional responsibilities include abiding by company rules and performing other assigned duties.

Requirements

• High School or GED HS Curriculum - Preferred
• 2 years or more in With HS/GED Experience in Pharmaceuticals Manufacturing
• Experience 3 years or more in Less than HS/GED proven related experience in Pharmaceuticals Manufacturing
• Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job. - Intermediate
• Ability to comprehend and follow written and verbal procedures or instructions - Intermediate
• Have basic math and mechanical skills - Intermediate
• Ability to operate forklift and pallet movers. - Intermediate
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

• Document activities in production batch records and log books.
• Maintain and monitor complete operation of softgel encapsulation.
• Maintain 100% cGMP and Compliance during complete operation of softgel encapsulation.
• Responsible for in-process documentation in all Softgel operations.
• Responsible for In-Process checks like average weight, ribbon thickness, shell weight, fills weight, physical defects like odd shapes leakers etc.
• Responsible for area cleanliness of the encapsulation room or assigned place of work and for proper status labeling.
• Proper usage of Safety and Protective Gears (PPE) and Dress Code.
• Monitor the Room temperature and Humidity where ever the product demands.
• Inform any abnormal sounds coming from the machine when the machine is in running condition to the supervisor or his designee.
• Run the softgel encapsulation machine as per the product specifications which are written in the batch record.
• Maintain the weighing scales neat and clean to check the calibration status. Inform the supervisor if calibration status is out of due date.
• Run the softgel encapsulation machine at the optimum speed.
• Stop the machine if softgels are found to be of inferior quality.
• Clean all gelatin manufacturing equipment including holding tanks, homogenizers and melting tank after use as per established procedures.
• Assist in the manufacture of gelatin and fill material.
• Ensure the level of lubricant/mineral oil level in pump case is adequate before start-up.
• Make sure the machine has adequate ribbon lubricant (MCT) before starting batch.
• Check all gelatin and active solution holding tanks before the start of the Batch.
• Properly identify the gelatin type and fill material/API solution before encapsulation process.
• Abide by the Amneal's current rules and regulations regarding day to day business activities.
• Other duties as assigned.

Benefits

• Above-market, diverse and robust health and insurance benefits
• Significant 401(k) matching contribution
• Programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED