Project Engineer

Role Summary/Purpose:
The enterprise solutions organization is an initiative within GE LifeSciences that focus on establishing biopharmaceutical manufacturingcapacity for customers. By leveraging on the business units extensiveproduct portfolio an******** know-how the aim is to sell projects tocustomers who wants to set up their own manufacturing plant.

Essential Responsibilitie********
The Project Engineer will be responsible to support process an********design which includes but not limite******** the generation of relevantdesign documents including Process Flow Diagrams (PFDs), equipmentl******** utility re******** process ******** user requirementsspecification (URS), general specification (GS), equipmentconfigurations an******** approval packages. The Project Engineer willbe responsible for providing feas******** reliable an******** macrolevel design base******** customer needs an******** requirements.Hasresponsibility for the support of design an******** of FlexFactorye******** consumable an******** selection an********, utility re********automation re******** design documentation generat******** testingprotocol review an********.Support the design control process fromrequirements development an******** planning to final design approval bycustomer. Ensure applicable customer requirements specification (URS)can be met by the FlexFactory ******** an******** fulfille******** theen********.Interface an******** with a cross-functional team ofeng******** Process Design Engineers an********.Support to ensure thecompleteness of the TOP, equipment set-up for Functional Testing &FAT. Support Customers question******** during Factory Acceptance Test(FAT) an******** FAT deviation punch list.Coordinate the detaile********an******** any design issues during the design an******** phasean******** as a contact for system design relate********.Participates indeveloping an******** the project schedule.Duties include:Supportcustomer meetings by providing system hardware understanding. Develop,explore an******** manufacturing concepts to fit customer need********requirements.
• Assure compliance with the GEHC Quality Manual, Quality ManagementSystem, Quality Management Pol******** Quality Goals, an******** lawsan******** as they apply to this job type/position
• Work closely with Customer’s Subject Matter Experts (SMEs) to ensurecontinuous exchange of critical an******** information neede********execute design activities on time
• Complete all planne******** & Compliance training withindefine********
• Identify an******** any quality or compliance concerns an********immediate corrective action as required
• Work closely with Process Design Engineers to ensure that theequipment specification meets customer an******** nee******** an********equipment layout is optimize******** the customer facility.
• Ensure compliance/closure of Regulatory an******** requirements beforeapproving Design Control FDRs an******** program milestones
• Lea******** improvement activities by driving the implementation ofprocess an******** quality improvement initiatives
• Approximately 30% travel depending on project specifics an********location

Qualification********
• BS or MS degree in biochemical / chemical engineering or arelate********/life Science discipline
• Minimum of 5 years of relevant bioproce******** experience
• Working knowledge of pharmaceutical/biotech processes, equipmenthar******** an******** use technology
• Engineering backgroun******** problem solving
• Thorough knowledge of biologics CMC, cGMP manufacturing requirements
• Technical understanding of automation systems use******** thebiopharma (Delta V, PLC, PI, etc.)
• Experience in working/leading within cross functional teams
• Experience with AutoCAD, V******** MS Project, SuperPro
• Fluent in English an******** both verbally an******** writing

Desire****************
• Master’s Degree
• Disposable technology design an******** experience
• 2 years of direct working in facility design or operations in a cGMPfacility
• Detail or******** excellent at critical analysis an******** solving
• Experience working in global business environment with soun******** ofglobal processes
• Dr******** clear thinking an******** excellent communicator
• Structured, organ******** Analyt******** Team oriented