NJ Employer Sr. Process Expert in Morris Plains, New Jersey
236738BR Sr. Process ExpertJob DescriptionProvide front line support for all process-specific issues to production, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.Business Process & Improvements: * Lead for identifing opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Program (OpEx). * Lead the effort to design, execute, and analyze process technical batches to generate sufficient process knowledge by thoroughly testing critical variables. * Oversees manufacturing pre-production technical planning to ensure timely and required batch processing by the manufacturing team. * Provide timely updates to management on status of all GMP-related projects * Work with regulatory department to ensure process related improvements are handled appropriately within regulatory framework and timelines * Is a resource to other departments as Subject Matter Expert for the product and process knowledge * Oversee and coordinates change control for process and product-related changes. Deviations, Investigations, and CAPAs: * Author investigations, CAPAs, and CAPA effectiveness checks related to process within required timelines * Communicate and coordinate with other departments, Technical Research & Development, Manufacturing Science & Technology, Training, Clinical, Commercial as examples, on deviations, investigations and CAPAs * Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.) * Use process knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures. Shop Floor Support: * Provide front line technical and procedural support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements. * Provides lastest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs. * Leads decision making effort for typical process interventions required. * Build technical knowledge and culter to Empowers associates to react appropriately to unplanned situationse Technology Transfer: * Provide timely support for process technology transfer activities. Training: * Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position. Audit Support: * Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit.EEO StatementMinimum requirementsEducation*BS in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. *Desirable MSc. or equivalent experience.Experience:Minimum five years experience in GMP manufacturing role on the shop floor. *Proven process understanding (Pharma, GMP, Regulatory aspects).DivisionNovartis Technical OperationsBusiness UnitNTO BTDMCountryUSAWork LocationMorris PlainsCompany/Legal EntityNovartis PharmaceuticalsFunctional AreaTechnical OperationsJob TypeFull TimeEmployment TypeRegularThe Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.