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Enginera.se

Charlotte Wiig Ekström
Senior Project Manager
• Co-Founder of Enginera AB in 2005 • Project Manager for the “Facility of the Year”, rewarded by ISPE New York 2006 (Pharmadule) • Over 12 years within the Pharma Business • M.Sc. Chemical Engineering, Royal Institute of Technology, Stockholm • Project Management Institute - Certified Project Manager Professional (PMP) Working Experience

Enginera AB
2006 - Present
Project Manager, USA
Project Manager for an entire OSD Clinical Trial Facility. The project included detailed design including dimensioning and engineering, procurement, installation and IQ/OQ. Project Manager, Sweden
Project Manager for the Installation phase for the new product line. The new product line to meet increased capacity demands. The project includes design review, procurement, installation and commissioning. Mechanical Completion Q1 2008. Project Manager, Sweden
Project Manager for rebuilding an old plant to meet new capacity demands. The process to be changed from an open manually process to a fully automatic and closed process with higher GMP demands. The project includes design, procurement, installation, commissioning and qualification of the equipment. PQ batches in Q1 2008 Pharmadule AB
1999 - 2006
Project Manager, Project, USA
Project Manager for the vial part in the Fill Finish facility including vial washer, sterilization tunnel, filling machine, three freeze dryers, loading and unloading system, cold filling, LAF-units, dryers and stopper washer. The project includes design, procurement, installation, commissioning and qualification of the equipment. Project Manager, Project, Ireland
Project Manager for a stand alone API Kilo Lab installed in two modules. The kilo lab included one process room (two reactor skids and a filter nutche), a staging area, a vacuum room (vacuum pump and scrubber), a mechanical room (AHU, electrical cabinets and heating cooling units) and an office room. Total area of the kilo lab is 120sqm. Three of the rooms are ATEX classified. Hand-over according to time schedule and budget, November 2005. Charlotte Wiig Ekström
Project Manager, Project, USA Facility of the Year 2006
Project Manager for a turn-key project of a Fill & Finish facility (Aseptic Vial Filling and Nested High Speed Syringe Filling) of 62 modules covering 3500 sqm divided into two floors. Responsibilities were initiated at the start of detailed design. This design has been fabricated in modules and the process equipment procured, installed and tested in Sweden before transportation to USA for erection, commissioning and qualification. The project managed to hold the very short time schedule of 18 months, maintained a very good quality and the profit was better than budget. Project Manager, Basic Design, USA
Project Manager for the basic design work of a Clinical Trial Parenteral Manufacturing Facility in the USA. The production facility was for two filling lines, one large scale filling line on one floor and one small filling line on another floor. The small filling line was to be utilizing isolation technology. The project has been postponed and not started. Project Manager, Basic and Detailed Design, Ireland
Project Manager for the basic and detailed design work and start up of the project for a Clean Bulk Manufacturing Facility in Ireland. The facility consists of one building in three levels of 88 modules covering 5609 sqm. The building has four manufacturing steps: Dispensing, Dissolution and Crystallization, Filtration/Drying and Milling and Blending. Project Manager, Basic Design, Sweden
Project Manager for the basic design work for an Aseptic Vial Filling facility. Project Manager, Basic Design, Sweden
Project Manager for the basic design work for an Aseptic Vial Filling facility Project Manager for Process Equipment, Project, USA
Project Manager for Process Equipment and also the Qualification Responsible for an Aseptic Filling facility of 26 modules. Responsible for installation and qualification of stopper processor, three freeze dryers, loading and unloading system, vial washer and sterilizing tunnel. Astra Zeneca
1998 - 1999
Project Manager, Project, Sweden
Project Manager for a new laboratory, handling microbiological analysis for the bulk production division in Snäckviken. This project included all design, installation and procurement of the equipment as well as Project Manager, Project, Sweden
Project Manager Process Equipment for the refurbishment of a fine chemical plant for the Omeprazole Production Cell, API large scale production. The project including the equipment: centrifuges, filter dryer and clean room and for them to be designed, procured and installed. Charlotte Wiig Ekström
Pharmacia & Upjohn
1996 - 1998
Project Manager, Project, Sweden
Project Manager for Improvement projects for API large scale production. Project Manager, Project, Sweden
Project Manager for the development of a new Production Filter Technology. Process Engineer, Project, Sweden
Process Engineer for a new plant for Production of Egg-yolk Phospholipids including Filter dryers and Formal Education

1992-1996
Royal Institute of Technology, Stockholm: M Sc. Chemical Engineering, Biotechnology
1990-1992 Stockholm
University:
1986-1989
Technical High School, Stockholm
Laguage Skills
Training / Courses

Source: http://www.enginera.se/Charlotte_WiigEkstrom-CV.pdf

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