DSP Area Owner (5216)
DSP Area Owner – 5216 ADA
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a DSP Area Owner for an initial 12-month contract with high likelihood of extension for another year based in the Valais area, Switzerland.
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:
· Work/Residence permit or Swiss/EU citizenship required
· Bachelor’s degree in Engineering
· Minimum 8 years’ experience in a full-scale large molecule drug substance facility
· At least 5 years’ experience as an Engineering Package Owner
· Fluent in English and German
· 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
· Downstream 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
· Proficient in Navisworks and 3D model reviews to support online and offline area reviews
· Proficient in Technical process control tuning and Delta V recipe design