**Summary**: The Remote Senior Associate, Manufacturing Technical Support, provides support for all process-specific issues to manufacturing. **About the Role**: **Responsibilities**: - Authors manufacturing investigations and meets all targets for timely closure and CAPA completion. - Supports steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy. - 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. - Supports process optimization establishment and new technology introduction for continued productivity improvement, as appropriate. - Supports the execution of process validations, and short-term improvement projects, collaborating with all the relevant parties at shop floor to ensure accurate execution. Launch & Transfer - for the product(s) assigned. - Revises the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Hazard Analysis). - Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records. - Maintain processes at inspection readiness level. - Ensures that all critical parameters are within written Instruction (e.g.



Master Batch Record, Quality Risk Assessment, and Validation Protocol). - Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs. - Reviews protocols and reports for technical correctness. - Other related duties as assigned. **Requirements**: - Bachelor’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 2 years of work experience in biopharmaceutical based GMP manufacturing operations. - Master’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 1 year of work experience in biopharmaceutical based GMP manufacturing operations. - Fluent in English. Excellent oral and written communication skills. Strong technical writing ability required. - Travel, as required, to other internal sites (<10%). Division Operations Business Unit Innovative Medicines Location Mexico Site INSURGENTES Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V. Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No **Accessibility and accommodation**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Senior Associate, Manufacturing Technical Support (Baja California Sur)
🏢 Novartis
📍 Baja California Sur