Maintenance & Calibration Technician - 2nd Shift Job at Kindeva Drug Delivery/Summit Biosciences, Lexington, KY

TEhYTHlVQm1aZHh0blptSVpQNExXQnJQNkE9PQ==
  • Kindeva Drug Delivery/Summit Biosciences
  • Lexington, KY

Job Description

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.

Job Tags

Full time, Worldwide, Shift work, Afternoon shift,

Similar Jobs

Sushi Nakazawa NYC

Assistant General Manager Job at Sushi Nakazawa NYC

 ...Sushi Nakazawa is searching for a qualified candidate to join its management team as an Assistant General Manager. Sushi Nakazawa is a partnership between Restauranteur Alessandro Borgognone and Executive Chef Daisuke Nakazawa. Upon opening in August 2013, the restaurant... 

Capital One

Principal Financial Analyst Job at Capital One

 ...degree in a quantitative field (Finance, Accounting, Economics, Mathematics, Engineering) or...  ...internal stakeholders At this time, Capital One will not sponsor a new applicant...  ...the time of this posting. Salaries for part-time roles will be prorated based upon... 

SunSoft Online

Systems Network Engineer Job at SunSoft Online

 ...performance of the agencys infrastructure and applications. The engineer will collaborate closely with internal IT teamsincluding...  ...maintain a stable, reliable, and secure IT environment. The Systems/Network Engineer will have direct ownership and oversight of... 

Senior Helpers of Northern Utah

Elderly Home Caregiver Job at Senior Helpers of Northern Utah

 ...their families. Senior Helpers caregivers provide one-on-one personal care to help our clients remain safe and independent in their home. We fit your area of expertise to the seniors youll care for.If you are a caring and compassionate individual who enjoys caring... 

Black & Veatch Family of Companies

Lineman Apprentice 1 (GA) Job at Black & Veatch Family of Companies

 ...Job Summary Assist lineman in the installation or repair of cables or wires used in electrical power or distribution systems in accordance with all applicable plans, specifications, codes and industry standards. May erect poles and light or heavy-duty transmission towers...