? Participate?in?engineering?project?teams?to?design?aseptic?and?biotech?processing?facilities?with?specific?emphasis?in?one?or?more?of?the?following:?upstream/downstream?processing,?formulation,?washing,?filling,?capping,?sterilization,?CIP/SIP,?and?packaging
? Feasibility?studies?up?to?detailed?engineering
? Perform?specification?and?design,?installation,?start-up?and?commissioning;?turnover?of?documentation,?and?validation?activities
? Process?evaluation?and?optimization
? 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?design?through?qualification?of?Fermentors,?Bioreactors,?CIP?/?SIP?and?COP?stations,?fixed?&?mobile?process?vessels,?disposable?bioreactors?and?devices
? Experience?in?Clean?Utility,?CS,?PTW,?WFI,?Clean?gasses,?Equipment?and?system?specifications,?consumption?calculations,?energy?optimizations
? Successfully?interface?with?clients,?project?managers,?and?engineering?professional?and?coordination?between?client,?suppliers?and?sub-contractors
? cGMP/TGA/ISO?9000/EHS?internal?audits
? Define?and?review?validation?,?qualification?and?GMP?complains?related?regulations?,?code?and?standards?(?CFDA?and?international?GMP?shall?be?considered?)
? Coordinate?with?design?team?for?DQ?review?and?design?GMP?upgrade
? Other?tasks?assigned?by?Department?manager
Bachelor’s?Degree?:?Chemical?Engineering?/?Chemistry?/?Bio-medical?Engineering
15?-20?years?in?pharma?process
Type?of?Experience:
? Sound?knowledge?of?pharmaceutical?production
? Knowledge?of?Good?Manufacturing?Practice?(GMP)
? Equipment?design?and?system?specifications
? Utility?system?calculations?and?energy?optimizations
? Installation,?start-up?and?commissioning;?handover?of?documentation?activities
? Proficiency?in?spoken?and?written?Chinse?and?English.
? Diligence?to?solve?problems?and?finish?the?work?in?a?structured?manner
? Global?mindset?and?enjoy?working?in?a?multi-cultural?environment
? Result-oriented?and?have?a?well-structured?approach?to?your?work
? You?have?a?personal?drive?and?are?passionate?about?your?work