Kindeva Drug Delivery · 3 months ago
Maintenance and Calibration Technician - 3rd Shift
Lexington, KY, USA
Full-time
Onsite
Mid, Senior Level
5+ years expKindeva Drug Delivery is a company dedicated to making products that save lives and ensure better health for patients globally. The Maintenance and Calibration Technician will perform maintenance and calibration activities in a pharmaceutical cGMP manufacturing facility, ensuring the optimal performance of equipment and systems to support the production of life-saving medications.
Manufacturing
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
Qualification
Required
High school diploma or GED (required); Associate's degree or technical certification in electrical, mechanical, or industrial maintenance (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
Preferred
Experience in pharmaceutical, biotech, or GMP-regulated manufacturing (preferred)
Experience with device manufacturing and equipment processes
Experience with PLC (Programmed Logic Controller) troubleshooting, programing 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)
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
MarketScreener
2026-01-01
Company data provided by crunchbase