Manufacturing Specialist

4 days ago

Nashville, Tennessee, United States August Bioservices Full time
Job Summary

We are seeking a highly skilled Manufacturing Technician to join our team at August Bioservices. As a key member of our manufacturing department, you will be responsible for cleaning, assembling, and sterilizing equipment, as well as maintaining the cleanroom environment and instruments.

Key Responsibilities
  • Operate processing equipment in accordance with SOPs, following GMP and GDP principles.
  • Use proper aseptic technique while performing all GMP activities, without compromising aseptic conditions.
  • Clean equipment pre-use and post-use, utilizing semi-automated, automated, and manual processes.
  • Pre-use and post-use integrity testing of filters.
  • Assembly of equipment to be used in aseptic formulation and filling operations.
  • Wrapping of parts, equipment, and filter assemblies and tools in preparation for sterilization.
  • Loading, operating, and unloading of the autoclaves.
  • Loading and unloading of HEPA transfer cabinet.
  • Support the loading and unloading of terminal sterilization autoclave.
  • Transfer of materials using proper sanitization processes per SOPs.
  • Perform material transfer sanitization per SOPs.
  • Perform cleanroom and equipment sanitizations per SOPs.
  • Actively participate in the completion of batch records, protocols, and all other GMP documents, following Good Documentation Practices.
  • Actively participate in troubleshooting processes and equipment problems, as well as assisting the manager in completing all necessary paperwork associated with investigations, deviations, and remarks.
  • Demonstrate proficiency as outlined in training requirements for equipment systems and position.
  • Recognize and report deviations or potential issues immediately to the management team.
  • Communicate and report status of equipment maintenance related issues to the area leadership and assist with actions necessary to resolve issues.
  • Perform all job responsibilities in compliance with applicable EHS, GMP, SOP regulations, guidelines, and policies.
  • Participate in training related to all sub-departments within the Manufacturing Department, to include material transfer, cleaning/sanitization, formulation, equipment preparation, filling, sterilization, inspection, and packaging.
  • Periodically take on other responsibilities in support of all Manufacturing activities as needed to support the business.
Requirements
  • 1+ years of experience in a manufacturing, equipment, or highly regulated environment.
  • High School Diploma or equivalent.
  • Physical requirements include stooping, standing, climbing, and lifting between 30 - 50 lbs.
  • Ability to establish and maintain working relationships cross functionally including production, QA, QC, engineering, validation, and maintenance.
  • The ability to communicate effectively, both verbally and in writing, to all levels within the organization.
  • Position may require employees to work in a 24/7 rotational schedule, including holidays and weekends, with overtime as needed.
Shift Differential Opportunity
  • 2nd shift Technicians are given the opportunity to receive an extra $2/hour worked on 2nd shift.

Upon qualification in the above functions, Technicians will be given the opportunity to cross train in filling operations, formulation and component preparation, packaging operations, and inspection.

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