Sterile Operations Specialist
2 days ago
We are seeking a highly skilled Sterile Manufacturing Technician to play a key role in the start-up of our facility, establishing efficient and safe sterile filling operations.
The ideal candidate will have previous experience working in a cleanroom environment, specifically in sterile filling and visual inspection, with a strong preference for candidates with isolator vial and syringe filling experience in a start-up setting.
Main Responsibilities- Demonstrate technical knowledge and expertise in recombination, pooling of drug substance, and aseptic filling in an isolator environment.
- Perform operational tasks related to recombination, pooling, sterile filling, and visual inspection in accordance with established standard operating procedures.
- Responsible for creating, updating, and executing batch records, SOPs, and other GMP documentation.
- Proactively identify equipment issues and perform root cause analysis, implementing effective solutions.
- Lead and support continuous improvement initiatives within the sterile filling facility.
- Previous experience in a highly regulated sterile filling facility is required.
- A high mechanical aptitude and capability are desired along with technical experience.
- Candidates must be conscientious, possess strong teamwork and interpersonal skills, and demonstrate commitment to a high level of safety awareness.
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