Manufacturing Technicians will clean, assemble, wrap, and sterilize equipment, filter assemblies and tools for the formulation and filling operations. Equipment and material transfer throughout the classified cleanrooms is required to support all production operations. Technicians will be responsible for maintaining the cleanroom environment, instruments and the stocking of supplies and gowning materials. Sanitizations of instruments, equipment and all GMP classified areas is required to maintain a low bioburden control.
Responsibilities
- Operate processing equipment in accordance with SOPs, in classified areas following GMP and GDP principles.
- Use proper aseptic technique while performing all GMP activities, without compromising aseptic conditions while working in Grade B/C/D/CNC environments.
- Cleaning 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 pes 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 (GDP).
- 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
