Maintenance and Calibration Technician - 2nd Shift

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make:

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.

Responsibilities:

Maintenance and Calibration

• 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.

Safety and Compliance

• 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.

Documentation and Reporting

• 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.

Qualifications:

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 + 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 Skills:

• 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)

Physical Requirements:

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

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