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Production Equipment Specialist

2 months ago

Lexington, Kentucky, United States Kindeva Drug DeliverySummit Biosciences Full time
Job Overview

Kindeva Drug Delivery is a prominent global contract developer and manufacturing organization (CDMO) specializing in advanced delivery platforms, including Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. Our Lexington facility is dedicated to the development, production, and commercialization of prescription nasal spray products and is experiencing significant growth. We collaborate with our clients to enhance patient outcomes globally.

Position Summary

The Manufacturing Technician plays a crucial role in the cleaning, sanitizing, operating, and maintaining of process equipment utilized in the production of sterile nasal spray drug products. This position also involves meticulous documentation practices.

Work Schedule

This is a full-time position with Third Shift hours from 11:00 PM to 7:30 AM, Monday through Friday, including potential overtime on Saturdays.

Key Responsibilities
  • Adhere to Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during manufacturing.
  • Follow Standard Operating Procedures (SOPs) for cleaning, sanitizing, and preparing process equipment for production.
  • Complete PBRs, Log Books, Forms, and other necessary documentation, assisting in the compilation and review of lot records prior to submission to Quality Assurance.
  • Draft and update SOPs and Forms to accurately reflect current practices.
  • Maintain a clean, organized, and well-stocked manufacturing area.
  • Support the training of fellow manufacturing team members.
  • Coordinate manufacturing, calibration, and maintenance activities with other departments.
  • Assist in writing, executing, and reviewing validation protocols for manufacturing and support equipment.
  • Lead initiatives for manufacturing or facility-related improvement projects.
  • Participate in routine preventive maintenance of facilities and equipment.
  • Identify opportunities for continuous improvement and cost savings.
  • Comply with cGMPs, SOPs, and safety policies.
Candidate Qualifications
  • Strong organizational skills and attention to detail.
  • Excellent interpersonal and communication abilities.
  • Positive attitude and motivation for continuous learning and self-improvement.
  • Flexibility and adaptability, with the ability to work independently and collaboratively.
  • Demonstrated strong work ethic in a lean, action-oriented environment.
  • Proficient in written communication for creating SOPs and completing documentation.
  • Experience in the pharmaceutical sector is preferred.
  • Familiarity with Microsoft Word and Excel.
Educational Requirements
  • High School diploma or GED.
  • 0 - 5 years of relevant experience in a pharmaceutical manufacturing setting.
  • Experience with sterilization processes or aseptic techniques is preferred.
  • Ability to write SOPs and other cGMP documentation.
  • Qualified to handle controlled substances.
  • Strong interpersonal skills and ability to thrive in a team environment.

Kindeva Drug Delivery is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by applicable federal, state, and local laws. All employment decisions are based on qualifications, merit, and business needs.