Sr. Equipment Maintenance Mechanic I

Kindeva Drug DeliveryLexington, KY
122d

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. If you are ready to work for a purpose, join Kindeva Drug Delivery! Working on the KDD Manufacturing Team as a Manufacturing Technician, you will be responsible for performing maintenance and calibration activities in a pharmaceutical cGMP manufacturing facility and supporting the manufacturing of life-changing and life-saving prescription nasal spray medications. Optimizing Production Efficiency – A well-maintained facility can operate at peak performance, ensuring that medications are produced in sufficient quantities to meet patient needs globally. Ultimately, a Maintenance Technician’s expertise ensures that every dose of medication manufactured is safe, effective, and delivered on time—directly contributing to improved patient outcomes worldwide.

Requirements

  • High school diploma or GED (required); Associate’s degree or technical certification in electrical, mechanical, or industrial maintenance (preferred).
  • Experience in pharmaceutical, biotech, or GMP-regulated manufacturing (preferred).
  • 5+ years hands-on maintenance, calibration and process control experience with 1 + years of experience in cGMP pharmaceutical or highly regulated setting.
  • Strong understanding of mechanical, electrical and instrumentation systems.
  • Ability to read and interpret technical drawings, manuals, and calibration specifications.
  • Troubleshooting and problem-solving ability.
  • Excellent communication and interpersonal skills.
  • Ability to work in varying environments, including clean rooms, production areas, and laboratories.

Nice To Haves

  • Experience with device manufacturing and equipment processes.
  • Experience with PLC (Programmed Logic Controller) troubleshooting, programming and wiring.
  • Strong understanding of cGMP regulations, FDA requirements, and other relevant industry standards.
  • Previous experience with manufacturing and maintenance software and systems (e.g., CMMS, ERP, MES, SCADA, OSI PI).

Responsibilities

  • Operate, monitor, calibrate and maintain equipment and systems supporting manufacturing and laboratory operations.
  • Perform scheduled preventive maintenance on production and facility equipment to ensure optimal performance.
  • Troubleshoot and repair mechanical, electrical, and pneumatic issues with production equipment.
  • Troubleshoot facility and lab equipment including HVAC air compressors, autoclaves, boilers, water skids and stability chambers.
  • Respond to off-hour breakdowns and urgent maintenance needs on a rotating basis.
  • Perform instrument calibrations (temperature, RH, pressure, pH) ensuring accuracy and compliance.
  • Identify and report out-of-tolerance calibrations; initiate corrective actions and documentation.
  • Assist in the installation, commissioning, and decommissioning of equipment and systems.
  • Keep all plant systems and manufacturing equipment operating efficiently and in good repair.
  • Maintain assigned areas in a neat, orderly condition and in compliance with SOPs and cGMPs.
  • Complete and document emergency repairs in a timely, high-quality manner to minimize downtime.
  • Follow all workplace safety procedures and maintain a high level of safety compliance.
  • Perform maintenance tasks in classified areas, including clean rooms, while following gowning requirements.
  • Ensure all work complies with internal policies, cGMPs, FDA, and other regulatory requirements.
  • Maintain accurate and detailed records of maintenance activities, calibrations, and repairs.
  • Complete calibration records and equipment logs in compliance with SOPs and regulatory standards.
  • Adhere to SOPs for all maintenance, calibration, and validation tasks.
  • Communicate effectively with stakeholders at all levels to ensure seamless shift transitions and minimal disruption to operations.
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