Amneal Pharmaceuticals-posted about 1 year ago
Full-time • Entry Level
Piscataway, NJ
Chemical Manufacturing

The Topicals Operator II is responsible for the setup, operation, and cleaning of various processing equipment in the Topical Department at Amneal Pharmaceuticals. This role involves executing production schedules, ensuring compliance with cGMP and SOP regulations, and maintaining documentation accuracy. The operator will also support other departments as needed and participate in training new operators.

  • Set up, operate, and clean all Topical Department process equipment.
  • Execute the Production Batch Record as written without deviation.
  • Ensure compliance with cGMPs, SOPs, and OSHA regulations during batch execution.
  • Maintain 100% documentation accuracy on all GMP documents.
  • Ensure cleanliness and organization of processing suites and related areas.
  • Promptly fill in processing equipment and environmental log books with accurate records.
  • Report any issues or concerns to the department supervisor that may impact batch execution.
  • Work closely with Technical Writer to generate detailed equipment SOPs.
  • Support other department activities such as Packaging and Pharmacy when not needed in Manufacturing.
  • Participate in generating Task Qualification Checklists for the Certified Trainer Program.
  • High School diploma or GED required.
  • 3 years or more in a pharmaceutical manufacturing environment.
  • Familiarity with Becomix, Adams Mixers, Ross Mixers, Unimix, or other cream/ointment processing equipment.
  • Mechanical ability.
  • Ability to read, write, perform basic math calculations, and communicate in English.
  • Previous experience operating pharmaceutical processing equipment, particularly mixers, blenders, processors.
  • Lean Six Sigma training/experience.
  • Excellent written and verbal communication skills in English.
  • Analytical problem-solving and troubleshooting skills.
  • Ability to train and cross new operators on equipment setup, operation, and cleaning.
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