Kindeva Drug Delivery is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows. If you are ready to work for a purpose, join our team!
Compensation and Benefits: This is a full-time, salaried position with a competitive compensation package including benefits such as health insurance, 401(k) plan, paid time off, and opportunities for career growth.
Job Summary: T his position is responsible for performing maintenance and calibration activities in a pharmaceutical cGMP manufacturing facility. This includes following procedures to perform and document instrument calibrations, preventive maintenance, troubleshooting and repair process equipment, utility, and facility issues and proactively improving existing and new equipment, utilities, and facilities. Additionally, manage the inventory of spare parts and provide technical input for new equipment purchases and plant expansion activities.
Essential Duties:

• Operate, monitor, calibrate, and maintain equipment and systems used to support manufacturing and laboratory operations.
• Complete PM records, equipment logs, and other forms to document work activities.
• Maintain an adequate inventory of spare parts for all plant and manufacturing equipment.
• Complete emergency repairs in a high-quality, timely manner to minimize downtime.
• Discover, evaluate, and recommend mechanical, electrical, control systems, or equipment upgrades toimprove quality, safety, and reliability and reduce costs.
• Write and revise SOPs, PM cards, and Forms to maintain up-to-date and accurately reflect the current procedures.
• Keep all plant systems and manufacturing equipment operating efficiently and well-maintained.
• Maintain assigned areas neat and orderly and in compliance with SOPs and cGMPs.
• Perform validation and equipment qualification activities.
• Other duties as assigned.

Candidate Attributes:

• Excellent organizational skills and attention to detail.
• Motivated to perform work while maintaining a focus on long-term learning and self-improvement.
• Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
• Must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners.
• Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic.
• Strong listening, writing, reading, and verbal communication skills.
• High School Diploma or equivalent
• Minimum of 2-5 years of previous work experience in maintenance, calibration or related trade.
• HVAC certification, trade school, or engineering education is preferred.
• Experience maintaining or calibrating equipment and utilities such as sterilizers, ovens, USP water systems, HVAC systems, and precision manufacturing equipment is preferred.
• Good written communication skills to read and write SOPs and complete cGMP documents.
• Good interpersonal skills and the ability to work well in a team environment.
• The ability to read and program PLC programs is a plus.