Job Details

Job Summary:

The Packaging Line Lead is responsible for overseeing the setup, operation, and documentation of the packaging line to ensure efficient, compliant, and high-quality production. This role coordinates with cross-functional teams, troubleshoots equipment issues, and ensures adherence to batch production records and regulatory standards.

Key Responsibilities:

Line Preparation & Setup

• Confirm line clearance prior to each new lot and ensure complete setup per batch production record (BPR), including filler hoses, nozzles, screens, pumps, and other components.
• Assemble and connect equipment and filler parts, verifying proper cleaning and documentation.
• Stage and verify labeling and packaging components, ensuring accuracy of lot numbers and expiration dates.
• Coordinate product changeovers, including pre-staging of equipment parts and materials, disassembling equipment, cleaning per SOPs, and reassembly.

Production Monitoring & Troubleshooting

• Monitor equipment performance throughout production, ensuring operational criteria (e.g., filler speed, mixing speeds, sealing temperatures, portable tank condition) meet BPR specifications.
• Ensure continuous supply of containers and closures in coordination with Material Handlers.
• Collaborate with Maintenance, QA, and Supervisors to identify and resolve process issues, documenting all occurrences in the Packaging Record.
• Work with QA to verify fill volume/weight and make necessary adjustments to meet lot specifications.
• Operation of packaging equipment as part of the line crew

Documentation & Compliance

• Accurately complete all required documentation in the Packaging Records and associated logbooks.
• Perform SAP transactions related to packaging runs.
• Review batch records and line logbooks to ensure proper documentation and compliance with SOPs and regulatory standards.
• Ensure changeover activities and time are accurately recorded in appropriate systems.

Leadership & Coordination

• Organize and direct the work of Packaging Personnel on assigned lines/shifts, provide guidance, answering questions, providing clear and concise communication, demonstrating conflict resolution abilities and conducting training as needed.
• Communicate effectively with other departments regarding labeling, packaging components, equipment status, and production challenges.
• Interface with QA, Validation, and Maintenance to ensure line readiness and timely completion of preventive maintenance procedures.
• Demonstrate Empathetic understanding, effective listening and have ability to provide constructive feedback.

Quality & Safety

• Monitor cleanliness and orderliness of work areas, ensuring compliance with safety, GMP, and regulatory requirements.
• Ensure all operations follow company policies, procedures, and applicable State, Federal, and Local laws.
• Identify opportunities and challenges related to compliance with Quality / EH&S and escalate for proactive elimination of risks.

Required Skills/Abilities:

• Must be able to speak and read in English.
• Ability to perform basic Math computations.
• Follows verbal and written directions.
• Communicates clearly and concisely, both orally and in writing.
• Establishes and maintains cooperative working relationships with others.

Education and Experience:

• High School Diploma or equivalent
• Experience in Manufacturing processes and equipment procedures.
• 2-5 years of experience in pharmaceutical, medical device, and/or food manufacturing
• Knowledge of Current Good Manufacturing Practices (cGMP's).
• Familiarity with the Food and Drug Administration (FDA), and other regulatory requirements.
• Understanding of SOP's, equipment and safety practices.

Physical Requirements/ Working Conditions:

Employees in this position are subject to extended periods of sitting, standing, walking, pushing, pulling, bending, vision monitoring, lifting equipment or materials up to 30 pounds.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products-including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances-is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled