Manufacturing Setup Technician

Kindeva Drug Delivery•Lexington, KY

1d•Onsite

About The Position

As a Setup Technician, Manufacturing, you will play a critical hands-on role in keeping our Filling, Assembly, and Packaging operations running safely, efficiently, and compliantly. You will be responsible for equipment setup, operational verification, troubleshooting, production execution, clearance, and changeovers while ensuring adherence to established procedures and Good Manufacturing Practices (GMP). You'll also serve as an equipment Subject Matter Expert (SME), working closely with Manufacturing, Engineering, and Maintenance to troubleshoot equipment and process issues, support and train team members, and continuously improve equipment setup and performance.

Requirements

High school diploma or equivalent.
2+ years of Good Manufacturing Practice (GMP) manufacturing experience with specific focus on equipment setup, operation, and troubleshooting.
Ability to make sound decisions regarding compliance-related issues with moderate supervision.
Strong knowledge of GMP, Standard Operating Procedures (SOPs), and production processes in a regulated environment.
Excellent communication, leadership, and organizational skills.
High level of personal and departmental accountability and responsibility.
Ability to work effectively within a team environment to maximize efficiency and throughput.

Responsibilities

Lead and perform production room release, equipment setup, operational verification, clearance, and changeover activities for Filling, Assembly, and Packaging operations.
Help ensure equipment is properly set up, verified, and ready to support production execution.
Perform work in accordance with established procedures and GMP requirements.
Serve as an equipment SME and key point of contact for equipment and process troubleshooting.
Troubleshoot mechanical and operational equipment issues and make appropriate adjustments to support equipment performance.
Partner with Engineering and Maintenance personnel to identify and resolve equipment and process issues.
Help ensure team members are fully trained on equipment, processes, and GMP standards associated with the setup, operation, and maintenance of production equipment.
Maintain up-to-date training records.
Provide ongoing coaching and development to team members.
Identify opportunities to improve equipment performance, processes, efficiency, and throughput.
Collaborate with cross-functional teams to implement Lean manufacturing initiatives and other continuous improvement strategies.
Coordinate with technicians, Manufacturing leadership, and support departments to ensure smooth transitions between production processes.
Work collaboratively across functions to maximize efficiency and throughput while maintaining safety, quality, and compliance expectations.