Production Equipment Specialist

2 weeks 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 delivery platforms such as Autoinjectors, Inhalation, Transdermal/Intradermal Patches, and Nasal Spray Technologies. Our Lexington facility is dedicated to the development, production, and commercialization of prescription nasal spray products and is currently experiencing significant growth. We collaborate with our clients to enhance patient outcomes globally.

Compensation and Benefits: This position is full-time and salaried, offering a competitive compensation package that includes health insurance, a 401(k) plan, paid time off, and opportunities for professional advancement.

Position Summary: The Production Equipment Specialist is tasked with the cleaning, sanitization, operation, and maintenance of process equipment utilized in the manufacturing of sterile nasal spray drug products, along with the completion of necessary documentation.

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 production, as well as for cleaning and sanitizing rooms as needed.
  • Complete PBRs, Log Books, Forms, and other 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 procedures.
  • Maintain the assigned manufacturing area in a neat, clean, and well-stocked condition.
  • 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.
  • Independently lead manufacturing or facility-related improvement initiatives.
  • Participate in routine preventive maintenance of facilities and equipment.
  • Identify opportunities for continuous improvement and cost savings.
  • Comply with current Good Manufacturing Practices (cGMPs), SOPs, and Safety policies.

Candidate Qualifications:

  • Exceptional organizational skills and attention to detail.
  • Strong interpersonal and communication abilities.
  • Self-motivated with a focus on long-term learning and self-improvement.
  • Flexible, adaptable, and capable of working independently as well as collaboratively across teams.
  • Ability to thrive in a lean, action-oriented environment while demonstrating a strong work ethic.
  • Proficient in written communication for reading and drafting SOPs and completing documentation.
  • Pharmaceutical experience 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.
  • Proficient in written communication for drafting SOPs and other cGMP documents.
  • 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.

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