Dsp Area Owner
vor 1 Woche
ROLE AND RESPONSIBILITIES
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 AND EDUCATION REQUIREMENTS
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 a engineering package owner on a full scale startup project
PREFERRED SKILLS
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 NOTES
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
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