AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing team. In this role, you will provide technical expertise across manufacturing processes and technologies, supporting the introduction of new products and technologies, the optimization of existing operations, and the resolution of day-to-day technical challenges.
You will work closely with colleagues across Operations, Engineering, Quality, Validation, Technical Services, and other functions, as well as with AbbVie teams across the global network and external vendors and consultants.
This is an excellent opportunity for a technically minded professional with experience in biologics, pharmaceuticals, medical devices, or a related regulated manufacturing environment.
Key Responsibilities
- Act as the Operations point of contact for site projects involving the introduction of new technologies or products and the upgrade of existing equipment and processes.
- Provide technical support for day-to-day manufacturing queries, including support for change controls and CAPAs.
- Lead or support process improvement initiatives focused on manufacturing reliability, efficiency, quality, and cost reduction.
- Provide technical expertise for sterilization processes, including:
- Filtration
- Steam sterilization
- Ethylene Oxide (ETO)
- Gamma sterilization
- Support manual and automated cleaning processes to ensure compliance with regulatory and quality requirements.
- Provide technical support for depyrogenation processes and the effective removal of pyrogens from components.
- Support lyophilization processes, including freeze-drying and vacuum-drying operations.
- Provide technical expertise for Vaporized Hydrogen Peroxide (VHP) sterilization within cleanroom environments.
- Support the design of facilities and utilities relevant to manufacturing processes, ensuring compliance and operational suitability.
- Act as a technical authority for aseptic processing, including vial, cartridge, and syringe filling operations.
- Contribute technical expertise to ongoing risk assessments and process evaluations.
- Collaborate with cross-functional teams to implement innovative solutions that improve manufacturing performance and product quality.
- Ensure new technologies and products meet applicable regulatory, quality, safety, and operational requirements and can be effectively integrated into existing processes.
- Support departmental initiatives relating to safety, training, quality, and continuous improvement.
- Participate in recruitment activities and relevant interview panels when required.
- Travel occasionally to support project work and collaboration with other subject matter experts.