Lead GMP Equipment Setup Technician

Kindeva; Lexington (KY); On-site; USD 55,000 - 75,000; Full time

Job summary

Kindeva Drug Delivery in Lexington, KY is seeking a Setup Technician, Manufacturing to ensure filling, assembly, and packaging operations run safely and efficiently. You will lead equipment setup, changeovers, and verification while adhering to GMP and SOPs, acting as a SME for equipment and cross-functional collaboration.

Responsibilities include troubleshooting, coaching teammates, and driving continuous improvement through Lean initiatives, with a focus on quality and throughput in a

Qualifications

• 2+ years of GMP manufacturing experience with equipment setup, operation, and troubleshooting.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Strong knowledge of GMP, SOPs, and production processes in a regulated environment.
• Excellent communication, leadership, and organizational skills.
• Ability to work effectively within a team to maximize 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 primary contact for troubleshooting; collaborate with Engineering and Maintenance to resolve issues.
• Train and coach team members on equipment, processes, and GMP standards.
• 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 and leadership to ensure smooth transitions between production processes.

Skills

GMP experience

Equipment setup

Troubleshooting

SOP knowledge

Team leadership

Communication

Education

High school diploma or equivalent

Job description

Kindeva Drug Delivery in Lexington, KY is seeking a Setup Technician, Manufacturing to ensure filling, assembly, and packaging operations run safely and efficiently. You will lead equipment setup, changeovers, and verification while adhering to GMP and SOPs, acting as a SME for equipment and cross-functional collaboration.

Responsibilities include troubleshooting, coaching teammates, and driving continuous improvement through Lean initiatives, with a focus on quality and throughput in a