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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 worldwide.

Compensation and Benefits: This position is full-time and hourly, offering a competitive salary package along with benefits such as health insurance, a 401(k) plan, paid time off, and opportunities for professional advancement.

Position Summary:

The Manufacturing Technician plays a crucial role in the cleaning, sanitizing, operation, and maintenance of process equipment utilized in the production of sterile nasal spray drug products, along with completing the necessary documentation. The position operates during Third Shift hours.

Key Responsibilities:
  • Adhere to Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during production.
  • Follow Standard Operating Procedures (SOPs) for cleaning, sanitizing, and preparing process equipment for manufacturing.
  • Complete PBRs, Log Books, Forms, and other essential documentation. Assist in compiling and reviewing lot records prior to submission to Quality Assurance.
  • Draft and update SOPs and Forms to accurately reflect current procedures.
  • 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 manufacturing or facility-related improvement projects independently.
  • Participate in routine preventive maintenance on 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 and proactive attitude.
  • Motivated to engage in work while focusing on long-term learning and self-improvement.
  • Flexible, adaptable, self-driven, and capable of working both independently and collaboratively.
  • Ability to thrive in a lean, action-oriented environment and demonstrate a strong work ethic.
  • Proficient written communication skills for drafting 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.
  • Qualified to handle controlled substances.
  • Strong interpersonal skills and the ability to work effectively 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.