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Specialist, Manufacturing Technical Support

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**Summary**: The Specialist, Manufacturing Technical Support, provides expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards. **About the Role**: **Responsibilities**: - Revises master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis). - Ensures that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, and Validation Protocol). - Supports steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy. - Ensures that all process changes in assigned products are managed through appropriate change control procedure. - Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records. - Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations. - Authors manufacturing investigations and meets all targets for timely closure and CAPA completion. - Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs. - Performs first line evaluation of product and process related issues (deviations, complaints, OOS, OOE). - Provides and supports assessments of technical changes, establishment of root-cause analysis, Quality Risk Assessment and process control strategies. - Maintains processes at inspection readiness level. - Supports process optimization establishment and new technology introduction for continued productivity improvement. - Reviews validation protocols and reports for technical correctness. - Revisions to the master manufacturing documents of assigned products. - Other related duties as assigned. **Requirements**: - B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations or 3 years relevant GTx experience. - Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. - In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. - Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. - Fluent in English. Excellent oral and written communication skills. Strong technical writing ability required. - Travel, as required, to other internal sites (