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Form of work365 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
