Senior Maintenance and Calibration Technician Position

Overview

Senior Equipment Maintenance Mechanic at Kindeva Drug Delivery plays a critical role in ensuring the reliability, safety, and performance of manufacturing and utility systems within a pharmaceutical cGMP environment. You will support the production of life-changing and life-saving prescription nasal spray medications by keeping complex utility and process equipment operating at peak performance. Through technical leadership, troubleshooting skills, and regulatory focus, you will help minimize downtime, maintain compliance, and ensure every product is manufactured safely, efficiently, and on time.

• Equipment, Utilities & Technical Leadership:
  Serve as a Subject Matter Expert (SME) for at least one utility and/or process equipment system.
• Operate, monitor, and maintain utilities and production equipment supporting manufacturing and laboratory operations using Facility Monitoring Systems (FMS) and established SOPs.
• Perform scheduled preventive maintenance on utility and production equipment in a high-quality, timely, and safety-compliant manner to minimize downtime and ensure optimal operation.
• Perform corrective maintenance on utility and production equipment with a focus on root cause identification and long-term reliability.
• Troubleshoot and repair mechanical, electrical, pneumatic, and control system issues impacting manufacturing and utilities.

• Utilities: HVAC systems, air compressors, boilers, Purified Water and Clean Steam skids
• Process Equipment:
  Formulation and filling equipment, assembly and packaging machines, autoclaves, environmental and stability chambers

• 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.
• Identify and report out-of-tolerance conditions; initiate appropriate documentation and corrective actions.
• Manage vendor calibration activities, including scheduling, shipment coordination, return of equipment, review of vendor documentation, and hosting on-site service providers.

• Perform maintenance and calibration tasks in utility and classified areas, including clean rooms, while following gowning and safety requirements.
• Maintain accurate, detailed records of maintenance, calibration activities, repairs, and spare parts usage.
• Complete calibration records and equipment logs in compliance with SOPs and industry regulations.
• Ensure all work complies with internal policies, cGMPs, FDA, and other regulatory requirements.
• Follow all workplace safety procedures and maintain a high level of safety compliance at all times.

• Perform training tasks as assigned and within required timelines.
• Communicate effectively with stakeholders at all levels to ensure smooth shift-to-shift transitions and minimal disruption to operations.
• Respond to off-hour breakdowns and urgent maintenance needs on a rotating basis.
• Adhere to SOPs governing maintenance, calibration, and validation activities.

Basic Qualifications:

• High school diploma or GED required;
  Associate’s degree or technical certification in mechanical, electrical, or industrial maintenance preferred.
• 7+ years of hands-on maintenance and calibration experience in a regulated manufacturing environment.
• 3+ years of experience in a pharmaceutical, biotech, or other highly regulated cGMP setting.
• Strong working knowledge of mechanical, electrical, pneumatic, and control systems.
• Proven troubleshooting and root-cause analysis skills.
• Ability to read and interpret technical drawings, manuals, and specifications.
• Strong documentation, communication, and interpersonal skills.
• Ability to read and interpret technical drawings, manuals, and calibration specifications.
• 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, programming…