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 (<10%).