Senior Process Engineer BLS

该职位来源于猎聘 Highlight 资深工艺设计，面向生物制药行业； 职位方向：OSD/Sterilized；spray drying； Main Tasks & Responsibilities

• Familiar with OSD facilities design with specific emphasis in one or more of the following process: Weighing and dispensing, wet and dry granulating, milling and sieving, coating, tableting, blister packaging and secondary packaging.
• Familiar with OSD relative process equipment in one or more of the following process equipment: downflow booth, material lift, vacuum transfer, IBC with SBV, IBC washer, bin-blinder, granulator, tablet compressor, coater, blister packaging line and secondary packaging line.
• Familiar with Fill & Finish facilities design with specific emphasis in one or more of the following process: Weighing and dispensing, formulation, CIP/SIP, aseptic filling, isolator, TLU, inspection. Washing & sterilization.
• Development of URS, technical specifications, request for quotation, technical analysis and commercial evaluation of offers, follow-up of construction, pre-operational testing, installation commissioning and validation.
• Experience in WPO （work package owner）of process system in foreign-funded OSD projects and understanding WPO’s role and responsibility.
• Familiar with process equipment layout and the requirements for factory facilities
• Familiar with OSD/Sterilized process operation and background cleanness grade. Qualifications
• Bachelor’s Degree : Chemical Engineering /Food Engineering
• Minimum 5 years experience in OSD/Sterilized process design
• Experience in Process equipment (Life Science)
• Experience in Design criteria (GMP, ISPE, ASME, EP, USP)
• Experience in Process Calculation and Process Layout
• Experience in Regulatory Affairs