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

The Manufacturing Operator is responsible for the setup, operation, and cleaning of various processing equipment used in the production of creams, ointments, and lotions. This role requires strict adherence to production schedules and compliance with cGMP, SOPs, and OSHA regulations. The operator must ensure accurate documentation and maintain cleanliness in processing areas while also supporting other departments as needed.

  • Set up, operate, and clean all Topical Department process equipment.
  • Execute the Production Batch Record as written without deviation.
  • Document all specified tasks and actions as required.
  • 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 according to GMP guidelines.
  • Promptly fill in processing equipment, room, scale, and environmental log books with accurate records.
  • Report any issues or concerns to the department supervisor that may impact batch execution.
  • Work closely with the 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 and train new operators.
  • High School diploma or GED required.
  • 3 years or more experience in a pharmaceutical manufacturing environment, particularly with cream/ointment/lotion processing equipment.
  • Familiarity with Becomix, Adams Mixers, Ross Mixers, Unimix, or other cream/ointment processing equipment is a plus.
  • Mechanical ability is required.
  • Ability to read, write, perform basic math calculations, and communicate in English.
  • Lean Six Sigma training/experience is a major plus.
  • Previous experience operating pharmaceutical processing equipment, particularly mixers, blenders, processors, etc.
  • Train the Trainer experience is a major plus.
  • Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
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