Packaging Line Lead - 201 (D-shift)

About the role

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.

Responsibilities

• 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.
• 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.
• Operate packaging equipment as part of the line crew.
• 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.
• Organize and direct the work of Packaging Personnel on assigned lines/shifts, provide guidance, answer questions, provide clear and concise communication, demonstrate conflict resolution abilities and conduct 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.
• 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.