Process Expert

Novartis • Durham, CA

3d • Onsite

About The Position

The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines.

Major accountabilities: Shop Floor Support: Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements. Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs. Perform data analysis and identifies potential process shifts/trends and escalate as necessary. Deviations, Investigations, and CAPAs: Author investigations for product and non-product deviations. Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results. Work cross-functionally to assess deviation impact and identify root causes. Work with Scheduling and QA to ensure that batches of are released on time through the closure of robust investigations and impact/risk assessments. Use process knowledge and root cause investigation tools to analyze data and to identify and root causes of product and process failures. Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations. Support the process of escalation of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs). Business Process & Improvements: Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx). Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables. Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team. Provide timely updates to management on status of manufacturing performance. Escalate potential performance issues to 3rd parties. Technology Transfer: Provide timely support for process technology transfer activities from clients/3rd parties. Training: Develop and provide training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required. Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position. Coach new investigators as part of the Investigator Certification Program. Audit Support: Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit. Authorities' inspections

Requirements

• Bachelor's degree in Science, Engineering or Biology or related field or relevant experience in lieu of a degree
• 2+ years of relevant experience in a GMP environment is required with degree; 7+ years of relevant experience in lieu of a degree
• Previous GxP experience is required
• Excellent communication and collaboration skills

Nice To Haves

• Data Analytics
• digital skills
• General Hse Knowledge
• gmp knowledge
• process excellence
• Resilience

Responsibilities

• Provide front line technical and procedural support to manufacturing
• Perform data analysis and identifies potential process shifts/trends and escalate as necessary
• Author investigations for product and non-product deviations
• Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results
• Work cross-functionally to assess deviation impact and identify root causes
• Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations
• Support the process of escalation of deviations when appropriate according to escalation guidelines
• Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs)
• Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx)
• Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables
• Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team
• Provide timely updates to management on status of manufacturing performance
• Escalate potential performance issues to 3rd parties
• Provide timely support for process technology transfer activities from clients/3rd parties
• Develop and provide training to the Cell Processing team, as required
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position
• Coach new investigators as part of the Investigator Certification Program
• Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees