Jenny Algelid Bengtsson

Technical project manager for realization of the quality control laboratory to be built at the completely new NOVO Energy facility in Torslanda. Leading a cross functional team to align activities for construction, layout, media supply, procurement of lab-furniture and instruments, implement necessary health and safety measures as well as method development and creating work instructions. Responsible for alignment with project steering committee, coordination between functions, budget, resources and time schedule. Also Technical project manager for a project setting technical demands, purchasing, commissioning and qualify an at-line battery cell “Test and Validation” equipment. Responsible for budget, resources and time schedule as well as quality related activities to secure regulatory and customer compliance.

Project manager leading a team conducting a pre-study where increased production capacity for a current product shall be investigated. This includes procurement of production equipment and cooperation with external company where the equipment can be placed and operated. Responsible for budget, resources and time schedule.

Project manager for a project designing, building and commissioning an in-line product quality control equipment. Responsible for budget, resources and time schedule as well as quality related activities to secure regulatory compliance.

Leading internal working process projects as a part of the company’s continuous improvement initiative. The projects were about improving the way of working during the ramp-up phase for new process equipment in the factory and improvement of the Instruction for project management within Operations.

Coordinator for transferring production capacity to the company’s site in Turkey. Responsible for setting up the logistical flow of products and adapting the factories in Mölndal and Turkey to the new conditions i.e. modification of manufacturing control system and ERP.

Project manager for project building a new factory-part and developing updated products. Responsible for budget, resources and time schedule. Contact with project sponsor and company management regarding project progress. Project also includes work to move production of products not suitable for the new factory to production-site in Turkey.

Ramp-up manager for a new production line. Responsible for securing production volumes and quality. Extremely tight timelines as the new product was sold in higher volumes than expected.

Assignment at Wellspect, Mölndal Technical project manager in project building a new factory-part and developing updated products. Responsible for follow up on technical completion of the new factory and to reach capacity goals. From October also leader of a cross functional group within the line organization focusing on increasing capacity in the complete factory when integration the new parts.

Assignment at Wellspect, Mölndal Project manager for sub-project “Product convert and roll out” within a large project building a new factory-part and developing updated products for the hole catheter assortment. Leading a cross-functional R&D, RA, Q, MA (Clinical research), Marketing and Supply team to be able to CE mark and place the new products on all relevant markets, including resource and budget planning. Leading development of modified raw materials with sub-supplier to adopt to new production process implemented by the project. Also leading the convert activities in the factory to switch from the current to the new production process. Leader of “task force” team to quickly find solution to a problem which otherwise had delayed the project. Contact person for the project to organization leading the work to adopt to new MDR (EU legislation).

Assignment at Wellspect, Mölndal Validation leader within a project building a new part of the factory for coating of catheters. Leading a team of 3-4 validation engineers to plan, execute and report process validation activities and risk analysis for the new process. Supported the customer in development of internal ways of working and writing new instruction for software validation.

Assignment at Wellspect, Mölndal Process validation leader. Process validation of Navina rectal catheter. A challenging project where high level of innovations and new thinking within the frames of process validation was needed.

Assignment at Vitrolife, Göteborg Validation and verification manager in product development project. Planning, performing and reporting of both product verification activities as product verification and stability verification as well as product validation. Responsible for design in-put and out-put validation documentation. Coordination of regulatory applications. Process validation activities of new equipment and validation of new sterilization method. Supported the customer with developing working processes within process validation. Project leader of investment project for new temperature monitoring system for the production plant and warehouse including time planning, resources and budget. Writing of requirement specification, responsible for procurement, installation, commissioning and validation of the system.

Assignment at Wellspect, Mölndal Validation engineer in a project for capacity increase of production of urinary catheter products. Process validation of new packaging line for catheters.

Assignment at Propoint, Kungsbacka Part-time assignment. Validation leader for document management system and process validation of production equipment, mainly supporting and guiding Semcon colleagues who performed the validation. Introducing structure for process validation for the customer to be GAMP compliant.

Assignment at Wärtsilä, Göteborg Validation leader in “Emergency Diesel for Ringhals” project. Set up of validation strategy and performing validation activities.

Assignment at Ringhals Nuclear Power Plant, Varberg Validation engineer in the “Reactor Safety Enhancement project Ringhals 1”. The tasks included validation of hardware, software as well as infrastructure systems as HVAC and power supply. Implementation of new ways of working as validation of equipment and systems according to GAMP was introduces by Semcon at Ringhals along with this project.

Long-term assignment as Study Delivery Operation Specialist at AstraZeneca, Mölndal. Responsible for operational activities within a multinational clinical trial in accordance with GCP.