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Imagine what you could do here at Novartis!

The Senior Validation Lead provides Site with Subject Matter Expert (SME) knowledge and skills related to qualification/validation activities and requirements, for project management, specific pharmaceutical processes or process technologies and commercial manufacturing support.

Your responsibilities include, but are not limited to:

Validation
* Responsible for the generation and maintenance of the Site Validation Masterplan along with ensuring project deadlines are met in a timely manner
* Writes, reviews or approves validation protocols and reports under their area of responsibility (as needed).
* Works with the local MS&T team and site leadership team to define priorities on validation of new equipment as well as process/compliance improvements on existing processes and equipment.

Manufacturing Excellence - for the technology(ies) assigned:
* Contributes to harmonization and optimization of technical processes across the site.
* Supports the performance of process characterization of the related pharmaceutical processes to increase robustness and sustainability.
* Supports the Aseptic Expert(s) / Process Experts in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units.
Stewardship - for technologies assigned:
* Interfaces with local and global MS&T network and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment. Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge.
* Assures that the necessary benchmark is done internally and externally in the scientific community, to stimulate and to extend the knowledge and know-how of associates and sharing this knowledge with the rest of the organization.
* Expected to acquire and contribute technical expertise for equipment qualification around technologies within area of responsibility.

Launch & Transfer:
* SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production.

Training:
* Provide technical training, coaching and education for Process Experts and production operators.

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