Engineer

• Promotes a culture of safety
• Represents site MSAT on internal and external project teams as technical subject matter expert (SME)
• Interfaces with global MSAT, Manufacturing Operations and Quality functions
• Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
• Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions
• Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation
• Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
• Lead quality and technical risk assessment activities
• Support and/or lead technology transfer or new production introduction activities
• Provide training and technical knowledge sharing to manufacturing
• Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners
• Support and on-call rotating to support 24/7 operations
• Confident to act as a subject matter expert for regulatory and client inspection audits
• Apply Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities

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