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Senior Specialist, CTO MSAT Process Validation Engineer II

Bristol Myers Squibb

The Senior Specialist, Process Validation Engineer II is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply in the CTO Summit, NJ manufacturing site. The Senior Specialist develops and supports qualification and validation activities in a leading role (e.g. protocols, reports, site procedures and batch records, and agency filing content) satisfying internal and external regulatory expectations. The Senior Specialist will collaborate with Global MSAT as well as Product and Development, Manufacturing Operations (MO), Supply Chain (SC), Quality Control (QC) and Quality Assurance (QA) departments while providing technical support for the resolution of validation related project deliverables, evaluation and implementation of process changes and continuous process improvement support to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

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