Engineer

• Promotes a culture of safety
• Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions
• Possesses a deep understanding of downstream processes for the purification of biologics
• Authors, reviews and approves 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 Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration
• Is confident to act as a subject matter expert for regulatory and client inspection audits
• 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
• Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing
• Skilled at organizing data to optimize analysis and trending
• Experienced investigator and knowledgeable of root cause analysis tools (RCA)
• Support and on-call rotating to support 24/7 operations
• Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing.

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