Manufacturing 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

Open Positions:

• (1)- 1st shift (5:00 AM - 3:30 PM Monday-Thursday & every other Friday)
• (1)- 2nd shift (3 :00 PM - 1:30 AM Monday-Thursday & every other Friday)

The Impact You Will Make

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.

What You Will Do

Equipment Setup, Changeovers & Production Readiness

• 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.

Equipment Troubleshooting & Technical Support

• 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.

Training & Team Development

• Help ensure team members are fully trained on equipment, processes, and GMP standards associated with the setup, operation, and maintenance of production equipment.
• 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.

Shift & Team Coordination

• 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.

What You Will Bring

Basic Qualifications

• 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.

Physical Requirements & Work Environment

• Regularly use hands to handle materials and supplies.
• Use computers for extended periods during the workday.
• Communicate effectively by telephone and electronic means.
• Regularly stand and walk for extended periods.
• Occasionally lift and/or move up to 25 pounds.
• Use proper lifting techniques and maintain awareness of workplace hazards.
• Have adequate vision to read and execute documentation and perform job responsibilities compliantly and safely.
• Follow all site safety procedures.
• Work in an environment that may include high-potency chemical compounds, hazardous materials, toxic substances, and controlled substances.
• Adhere to stringent Personal Protective Equipment (PPE) requirements and safe work methods and practices to ensure the safety and quality of personnel and finished product.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Job Family B - Engineering - Equipment Set-Up Operations