Tasks
• Act as Pre Viral Lead for technical changes and change management associated with Installation, Automation, MSAT process changes, Operational changes• Act as an SME to support installation, construction and commissioning
• System owner approval of installation standard
• Design review Client lead for 3 chromatography rooms, viral filtration, depth filtration
• Responsible engineering support of 3 process fits
• Process Pre and Post approval of all CQV activities, in pre viral
Qualifications
• 10+ years of hands-on technical experience in large molecule drug substance , in Downstream• 5+ years of experience working with chromatography or depth filtration systems
• Experience with stainless steel equipment and Delta V software
• Strong understanding of design in all project phases and process operations in downstream
• Substantial SME skills within several domains, including collaboration with design partners, CQV, MES , MSAT, Operations
• Collaborative personality, strong decision maker, and ability to work independently
• Will interface: QA, CQV, Engineering, Design, Facilities
• Fluency in English