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Вид занятости: Полная занятость

Вакансия из области: Инженерия

Минимальное образование: Высшее

Минимальный опыт: 3 года

Рабочая виза: Паспорт ЕС

More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing. By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life. We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life. For this journey we need more skilled people to join! Site Project Management is a newly established department in ALK placed in the Product Supply organisation. We run engineering and process projects and consists of 27 dedicated employees all based at the ALK headquarter in Hørsholm. The positions As a Senior Engineer you will join the Engineering Project team which are responsible for scoping, planning and execution of engineering projects, support/implementation of larger CAPEX projects and running improvement initiatives. You will also support the organisation as SME for WFI or utilities in complex cases in daily operations. As a team we are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues. Your role of responsibility will be: Scoping and planning work packages in project activities for utility or WFI equipment.Ensure that implementation /improvements/changes on equipment fulfils GEP/GMP requirementsRole as participant, SME, and work package owner in CAPEX projects.Act as a professional utility/WFI expert with respect to the system and documentation including giving input on maintenance, service, and calibration requirements.Keep updated knowledge on guideline requirements and industry practices.Write investment applications, requirement specifications, validation plans and qualification documents, change requests, risk assessments, etc.Participate in trouble shooting in daily operations as SME for utility/WFI.Your daily tasks will include: Act as professional utility expert and provide input to maintenance, service, and calibrationPreparation and review of cases, e.g., DEV, CAPA, and CC-casesPreparation and approval of qualification documentationPlanning and execution of equipment/ utility qualification and commissioning.Approval of instruction e.g., SOP, WIN etc.Approval of technical documentsHandling of suppliers and consultant in projects.Handle actions and follow up on audits and inspectionsYour profile You hold a degree in Pharmaceutical Science, Engineering or similar with min. 5 years' experience in pharmaceutical industry working within the area of Utilities, Equipment, and qualification. You are experienced with building pharma and have in-depth knowledge of the construction function, including components and spare parts, material certificates and related documentation. Furthermore, you possess knowledge of standards and norms within utilities and have strong systematic and organising skills in the lifecycle of projects. You are fluent in Danish and English and have a work permit for Denmark. What we have to offer ALK is a global pharmaceutical company in progress offering unique job opportunities. ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. We consider our pioneering spirit coupled with our trustworthiness our winning formula. Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm.