Process Expert
Novartis
3 months ago
On-site
Morris Plains, NJ
$77,000 - $143,000 USD yearly
Operations
Responsibilities:
- Provide front line technical and procedural support to manufacturing (with the cell processing team), ensuring each batch is manufactured safely, on time, and in compliance with batch records and quality requirements.
- Share latest best practices and learning from investigation findings, CAPAs, and MST/TRD experiences with manufacturing SMEs.
- Perform data analysis to identify process shifts/trends and escalate as necessary.
Deviations, Investigations, and CAPAs:
- Author investigations for product and non-product deviations.
- Conduct manufacturing investigations for OOE/OOS/OOT results.
- Cross-functionally assess deviation impact and identify root causes.
- Coordinate with Scheduling and QA to ensure on-time batch release through closure of investigations and impact/risk assessments.
- Use process knowledge and root-cause investigation tools to analyze data and determine causes of product/process failures.
- Initiate CAPAs and conduct CAPA effectiveness checks to eliminate/mitigate deviations.
- Support escalation of deviations per escalation guidelines; clearly present escalation details (root cause and CAPAs) on time.
Business Process & Improvements:
- Identify opportunities for process, operational, and quality improvements with Manufacturing (PU) and Operational Excellence (OpEx).
- Execute process technical batches to generate sufficient process knowledge by testing critical variables.
- Evaluate pre-production technical planning and review incoming apheresis technical data to ensure timely batch pathway processing.
- Provide timely updates on manufacturing performance status and escalate potential performance issues.
Technology Transfer:
- Provide timely support for process technology transfer activities from clients/3rd parties.
Training:
- Develop and provide training for unexpected events, technical document execution, and new products/processes to the Cell Processing team.
- Own the training curriculum for this job profile and support training for new Process Expert associates.
- Coach new investigators as part of the Investigator Certification Program.
Audit Support:
- Maintain processes at inspection readiness level and support internal/external audits.
Minimum Requirements:
- Bachelor’s degree in Science, Engineering, Biology, or related field (required).
- 3+ years of relevant experience in the pharmaceutical industry (required).
- Previous GxP experience (required).
- Excellent communication and collaboration skills (required).
- Provide front line technical and procedural support to manufacturing (with the cell processing team), ensuring each batch is manufactured safely, on time, and in compliance with batch records and quality requirements.
- Share latest best practices and learning from investigation findings, CAPAs, and MST/TRD experiences with manufacturing SMEs.
- Perform data analysis to identify process shifts/trends and escalate as necessary.
Deviations, Investigations, and CAPAs:
- Author investigations for product and non-product deviations.
- Conduct manufacturing investigations for OOE/OOS/OOT results.
- Cross-functionally assess deviation impact and identify root causes.
- Coordinate with Scheduling and QA to ensure on-time batch release through closure of investigations and impact/risk assessments.
- Use process knowledge and root-cause investigation tools to analyze data and determine causes of product/process failures.
- Initiate CAPAs and conduct CAPA effectiveness checks to eliminate/mitigate deviations.
- Support escalation of deviations per escalation guidelines; clearly present escalation details (root cause and CAPAs) on time.
Business Process & Improvements:
- Identify opportunities for process, operational, and quality improvements with Manufacturing (PU) and Operational Excellence (OpEx).
- Execute process technical batches to generate sufficient process knowledge by testing critical variables.
- Evaluate pre-production technical planning and review incoming apheresis technical data to ensure timely batch pathway processing.
- Provide timely updates on manufacturing performance status and escalate potential performance issues.
Technology Transfer:
- Provide timely support for process technology transfer activities from clients/3rd parties.
Training:
- Develop and provide training for unexpected events, technical document execution, and new products/processes to the Cell Processing team.
- Own the training curriculum for this job profile and support training for new Process Expert associates.
- Coach new investigators as part of the Investigator Certification Program.
Audit Support:
- Maintain processes at inspection readiness level and support internal/external audits.
Minimum Requirements:
- Bachelor’s degree in Science, Engineering, Biology, or related field (required).
- 3+ years of relevant experience in the pharmaceutical industry (required).
- Previous GxP experience (required).
- Excellent communication and collaboration skills (required).