Packaging Line Leader

Edison, United States, New Jersey, 08817

Job

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

Position Summary / Objective:
The role is primarily that of a Packaging Line Operator with the capability to function as a Line Leader when required. The individual will operate packaging lines and associated equipment, ensuring compliance with quality standards, safety regulations, and production goals. This position requires flexibility to lead line activities, coordinate setups and changeovers, and maintain smooth operations while adhering to cGMP, Safety and company procedures.

• Shift Time:
  Sunday - Thursday : 10:45pm - 7am

• Execute packaging operations in accordance with approved documentation.
• Initiate packaging batch operations on the line and enter required data into equipment and systems.
• Perform pre-start processes, including equipment inspections, system challenges, and in-process checks during the run.
• Conduct accuracy checks for finished goods aggregation during and at the end of the batch.
• Operate packaging lines and equipment per Packaging Batch Record to ensure maximum output, smooth/safe operation, and quality compliance.
• Identify opportunities for improvement in safety, quality, and productivity.
• Maintain a clean and orderly work area during operations; perform room, line, and equipment cleaning.
• Comply with company policies, SOPs, cGMP, DEA, and OSHA requirements.
• Assist in identifying health, safety, and ergonomic improvements through task analysis.
• Lead and coordinate line equipment setup, changeovers, cleaning, crew activities, housekeeping compliance, and line assignments.
• Monitor processes to proactively prevent deviations.
• Follow departmental SOPs, instructions, cGMP regulations, and Packaging Batch Records/Protocols.
• Verify packaging components and bulk products for accuracy.
• Complete required documentation in packaging batch records/protocols.
• Perform cleaning of packaging equipment, change parts, and lines.
• Maintain room/equipment logbooks accurately.
• Maintain operational knowledge of all packaging equipment and ancillary support devices, including control and communication systems.
• Notify management of any mechanical, material, or process issues promptly.
• Perform Material Handler tasks when required.
• Carry out other related duties as assigned by Supervisor/Manager.

• Education Required:
  
  High School Degree Required.
• Experience
  
  Required:
  
  1-2 years’ experience in FDA Regulated Environment desired. Specialized or Technical Knowledge, Licenses, Certifications required.
• Decision-Making & Problem Solving:
  Ability to make effective decisions based on deductive reasoning and potential product impact; respond to faults and error messages, assess product impact, and identify root causes.
• Technical
  
  Skills:
  
  Perform equipment adjustments to achieve desired output speeds and quality; navigate Operator Interface Terminals (OITs), including recipe entry, verification, and basic performance calculations; knowledge of aggregation processes on packaging lines.
• Operational Competence:
  Multi-task effectively, respond to alarms and indications, and interpret trends; capable of working extended hours and persevering under challenging conditions; ensure compliance with CGMP, SOP, DEA, Lock Out Tag Out, and OSHA regulations.
• Leadership & Training:
  Ability to train Packaging Line Leaders, Operators, and Material Handlers; build organizational capacity by leading problem-solving, principle-based decision-making, and…