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Manufacturing Operations Specialist
3 weeks ago
Job Description:
This role is a critical contributor to the establishment of sterile filling operations at our facility. As a Sterile Manufacturing Technician, you will play a key part in the start-up of a state-of-the-art flexible line using isolator technology for filling of vials and syringes.
- Support capital project execution, product transfers, and operational readiness activities.
Key Responsibilities Include:
- Attending equipment FATs, developing SOPs and batch records, generating training and qualification programs.
- Supporting equipment and process validation activities.
- Performing recombination and pooling of drug substance; filling line set-up and sterile filling operations.
- Operating parts washer and autoclave.
- Root cause analysis of equipment and process problems, and implementing effective solutions.
Required Skills and Qualifications:
- Demonstrate technical knowledge and experience in cleanroom operations.
- Excellent organizational skills.
- Strong communication and problem-solving skills.
- Leadership skills are highly valued.
Benefits of this Role:
This position offers the opportunity to work on various tasks related to equipment and process validation, sterile filling operations, and environmental monitoring. You will contribute to establishing a safe and efficient working environment by maintaining an exemplary personal training record and proactively identifying compliance risks and taking appropriate preventative actions.
