Maintenance and Calibration Technician - Third Shift

Overview

Maintenance and Calibration Technician - Third Shift at Kindeva Drug Delivery. This role involves 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.

• 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.

Basic Qualifications:

• 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+ year of experience in a 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

Skills:

• Experience with device manufacturing and equipment processes.
• Experience with PLC (Programmable 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).

• Regular use of hands for documentation, equipment operation, and material handling.
• Extended periods of standing and walking.
• Ability to lift/move heavy items and lift up to 60 pounds occasionally.
• Full range of vision capabilities (close, distance, color, peripheral, depth).
• Must wear required PPE and follow cGMP/safety procedures.
• Climb ladders and work in confined spaces as needed.

Equal Opportunity Employer

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.

Do you see yourself as part of the Kindeva mission? Apply today.