Tasks
-Equipment Owner for the DSP area of a CHO manufacturing facility containing chromatography, viral filtration and UFDF skids and associated process support equipment-Supporting the area from the end of detailed design to end of engineering runs of the first product introduction
-Supporting the internal project team for tech transfer
-Site point of contact and technical support for: Engineering design, Construction, CQV, Automation, Calibrations, MSAT, Plant engineering and operations
-Engineering signoff on all lifecycle documents
Qualifications
-Min bachelors engineering degree-Min 8 years’ experience in a full scale large molecule drug substance facility
-Min 5 years’ experience as an engineering package owner
-Has worked from design to commercial as an engineering package owner on a full scale startup project
-Detailed knowledge of CHO separation and purification processes
-CIP and SIP design for downstream
-Downstreamstream recipe design, Understanding all operational procedures
-Knowledge of DIN dimensional standards, typical piping specifications, and ASME-BPE
-Strong understanding of the design process on a large startup
-Strong understanding of the CQV lifecycle
-Understanding of tech transfer and MSAT process and process descriptions
-Used to working with vendors in support of site optimizations
Additional Information
-Being vocal without disruption within multi-disciplined design meeting-Proficient in Navisworks and 3d model reviews to support online and offline area reviews
-Proficient in Technical process control tuning and DeltaV recipe design