Aseptic Manufacturing Specialist

1 month ago

Brentwood, Missouri, United States Kindeva Drug Delivery Full time
Job Summary

Kindeva Drug Delivery is a leading global contract developer and manufacturer (CDMO) with expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes worldwide.

Role Overview

The Aseptic Specialist will observe and identify compliance deficiencies in the Aseptic Processing Area, partnering with Aseptic Operations to continuously improve aseptic behaviors and techniques. This role involves coaching and providing constructive feedback to aseptic personnel and management, as well as collecting and evaluating information to develop and implement improvements.

Key Responsibilities
  • Continuously observe and review aseptic practices on the manufacturing floor.
  • Provide immediate feedback to develop and improve colleague techniques and capabilities.
  • Identify opportunities related to aseptic processing microbiological science, microbiological control strategies, and environmental monitoring programs.
  • Implement projects to improve aseptic process compliance and support effective process operations.
  • Evaluate aseptic processes during air flow visualization studies.
  • Act as an active quality observation area lead during media fill simulations.
  • Maintain and update proper documentation, including SOPs, training records, batch records, and check sheets.
  • Participate in investigational activities related to environmental and behavioral compliance events.
  • Complete and maintain aseptic qualifications.
Requirements
  • Bachelor's degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science) preferred.
  • Previous experience in aseptic manufacturing preferred but not required.
  • Strong technical skills, including aseptic gowning and certification, attention to detail, and ability to hold self and others accountable.
  • Ability to communicate, present, and work well with all facility departments.
  • Must be able to read and write, as well as follow written and oral operating instructions.
  • Must be capable of performing data entry into office applications and using statistical software for data analysis.
Working Conditions

This role involves occasional lifting (less than 35 lbs.), reaching, and sitting while working at a computer terminal. Shifts are 2nd and 3rd.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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