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Job Details
Novartis
Multi-Discipline Engineer (Commission, Qualification, Validation)
Job Description
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Multi-Discipline Engineer will execute engineering activities (automation, qualification, maintenance, projects, etc.) Leads small semi-complex projects and compliance initiatives. He/she/they will work effectively in multiple engineering disciplines.
Your responsibilities will include, but are not limited to:
• Cross train on multiple discipline engineering areas (Automation, Qualification, Project, etc.) to gain a greater breath of overall department responsibilities.
• Support internal and external audits
• Own the Training Curriculum for own Job Profile
• Support and/or Lead general or semi-complex equipment, utility, facility improvement projects.
• Trains engineering specialists, operators and/or technicians
• Able to work collaboratively
• Perform troubleshooting and root cause analysis to develop robust CAPA plans for site issues
• Author and own quality activities (Deviations, Quality events, CAPA;s, Change Controls, Audit Actions, etc.)
• Develop and review SOPs
• Assist in the evaluation and reliability of equipment
• Support large and complex projects and those that are deemed high site priority.
• Identify technical solutions
• Prepare small project plans and documents.
• Support Project Health & Safety Risk Assessments (Equipment / Process)
• Perform new equipment FAT / SAT / inspections in project
• Perform commission tasks/activities
• Capable of foreseeing potential roadblocks to semi-complex issues (escalating as appropriate) and identifying solutions to remediate them.
• Develop test specification / plan for commissioning & qualification in projects
• Execute IQ, PQ and OQ protocols, and generate associated reports.
• Assist with the management of the automation systems at the site including building management systems (BMS), environmental monitoring systems (EMS), process and laboratory automation
• Support automation qualification activities
The Multi-Discipline Engineer will execute engineering activities (automation, qualification, maintenance, projects, etc.) Leads small semi-complex projects and compliance initiatives. He/she/they will work effectively in multiple engineering disciplines.
Your responsibilities will include, but are not limited to:
• Cross train on multiple discipline engineering areas (Automation, Qualification, Project, etc.) to gain a greater breath of overall department responsibilities.
• Support internal and external audits
• Own the Training Curriculum for own Job Profile
• Support and/or Lead general or semi-complex equipment, utility, facility improvement projects.
• Trains engineering specialists, operators and/or technicians
• Able to work collaboratively
• Perform troubleshooting and root cause analysis to develop robust CAPA plans for site issues
• Author and own quality activities (Deviations, Quality events, CAPA;s, Change Controls, Audit Actions, etc.)
• Develop and review SOPs
• Assist in the evaluation and reliability of equipment
• Support large and complex projects and those that are deemed high site priority.
• Identify technical solutions
• Prepare small project plans and documents.
• Support Project Health & Safety Risk Assessments (Equipment / Process)
• Perform new equipment FAT / SAT / inspections in project
• Perform commission tasks/activities
• Capable of foreseeing potential roadblocks to semi-complex issues (escalating as appropriate) and identifying solutions to remediate them.
• Develop test specification / plan for commissioning & qualification in projects
• Execute IQ, PQ and OQ protocols, and generate associated reports.
• Assist with the management of the automation systems at the site including building management systems (BMS), environmental monitoring systems (EMS), process and laboratory automation
• Support automation qualification activities