Fadel Jannuse Email & Phone Number

Projects:Fujifilm Diosynth Biotechnologies DenmarkRole: Package owner - Clean Utilities for new formulation and filling facility. (WFI, Clean Steam, Clean Air and Nitrogen)

Discipline lead/ Package Owner - Process engineering within Life Science and Pharma. Projects:Fujifilm Diosynth Biotechnologies DenmarkRole: Package owner - Clean Utilities for new formulation and filling facility. (WFI, Clean Steam, Clean Air and Nitrogen)Novo Nordisk PharmatechRole: Mechanical lead - new brown field production facility.

Københavnsområdet, Danmark

Planning and execution of projects within the pharma sector.• Project management (Scope management, manage time/economy, project risk management, stakeholder analysis, negotiation etc.)• Project management (CB, CD, BD, DD, execution, FAT/SAT, qualification, handover)• Defining design and requirements of production equipment• Specification/purchase of components and instruments• Responsibility/coordination of subcontractors in construction phase• Supervising the construction phase• Delivering documentation package• Test of equipment• Qualification of equipment (DQ, IQ, OQ, PQ)

Copenhagen Area, Denmark

As the responsible engineer for the API Purification Pilot Plant, I successfully maintain daily operations, as well as reconstruction/improvement projects.- Daily operations consists of securing a maintained and calibrated plant, handling and setting direction in case of unexpected issues as equipment performing out of specifications and breakdown. Handling of equipment related quality and compliance issues in non-conformities. - Coordination of projects during planned shutdowns- Implementing new production equipment and changes to existing production equipment (Design, CR, implementation, test & validation)- Management of minor projects, and participation in major projects.- Key person during authority inspections (DHMA, FDA etc.)

Professional in an API production facility.Work area: equipment- and process responsible of various utilities. Change Request cases, Projects (implementation/improvement of utility equipment and systems),Defining requirements for new and existing processes and equipment,Qualification and validation of production equipment and utilities (DQ, IQ, OQ, PQ),Non conformity cases, Handling incidents occurred during production, Writing and approving SOP’s, Trend reports,Participation in bigger projects and investments.Responsibilities across CVP areaCR-expert and representative for IM2 LCG group.- Key person during authority inspections (DHMA, FDA etc.)

Gentofte

Construction of a conveyor system for different types of vials (containing insulin) between a filling line and a freeze dryer. Complete design of the construction with all that it implies in terms of Drawings in 3D, 2D, finite element analysis, material selection, static/dynamic calculations. Construction made according to GMP regulated environment (aseptic production).

Bachelor'S Degree, Mechanical Engineering, 9,5 (Gennemsnit)

Mechanical Engineering 6Th Semester, Medical Devices, Vibrations, Sintering/Powder Injection Molding, English