Packaging Team Lead - 3rd Shift

Merck•Saint Louis, MO

2d•Onsite

About The Position

This role coordinates and participates in all aspects of filling, capping, torquing, and labeling of products in an ISO 13485 environment. The Packaging Team Lead is expected to complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products into inventory. This position is located at the South Ewing facility and operates on the 3rd Shift (Monday-Thursday, 8:30 PM - 7:00 AM).

Requirements

High School Diploma or GED
6+ months of packaging experience

Nice To Haves

Associate degree in Chemistry
Chemical weighing and chemical handling experience
Experience in ISO/GMP regulated environment
Experience leading teams or projects
Strong written and verbal communication skills
Strong experience with troubleshooting automated and semi-automated filling, capping, and labeling equipment
Strong time management/organizational skills
Strong computer skills including SAP and Microsoft Office
Mechanical skills to use pumps, electronic balances, and material handling equipment
Strong math skills including metrics and conversions

Responsibilities

Manage bulk pumping, small-scale pipette filling, filtration, and aseptic packaging operations while ensuring high-quality manual and automated processes.
Lead the shift in the supervisor's absence, provide daily guidance to operators, and play a key role in staff training, development, and interviewing.
Coordinate with manufacturing to prioritize time-sensitive make/fills, assist with daily schedule planning, and support the Daily Management System (DMS).
Maintain accurate, timely documentation for batch records and line operations utilizing SAP and computerized data collection systems.
Support site quality systems by complying with ISO 13485 and ISO 9001 standards, and assist with deviation investigations, change controls, and document updates.
Troubleshoot packaging equipment, verify calibration status, and assist with writing standard operations (Ops) and performing instrument/operational qualifications and validations.
Lead and champion automation, operational excellence, and process improvement projects to enhance safety, quality, and productivity.
Serve as a 3rd shift Emergency Response Team Member, identify and correct safety hazards, and participate in required safety training and inspections.
Maintain good housekeeping, support audit readiness, and actively participate in 6S workplace organization activities.
Provide recommendations for capital expense requests and offer technical support when evaluating new business development opportunities.