Senior Engineer, Utility Responsible

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Hørsholm

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 employ a team of 27 dedicated members all based at the ALK headquarter in Hørsholm.

The position

You will as Senior Engineer join the Engineering Project team who is part of Site Project Management. 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

  • Ensuring utility equipment is operating according to good engineering practice and where needed in GMP compliance
  • Ensure continuous upgrade and improvements of the utility, including scoping, planning, and managing activities. This should be done to ensure that the system is in operation in a valid and compliant state
  • Act as a professional utility 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
  • Obtain and keep an overview of utility records, SOPs, deviations, change controls, CAPA's etc.
  • Write investment applications, requirement specifications, validation plans and qualification documents, change requests, risk assessments, etc.
  • Participate in process related trouble shooting

Your daily tasks will include

  • Act as professional utility expert and provide input to maintenance, service, and calibration
  • Project participation e.g., package owner or as Utility SME
  • Preparation and handling of cases, e.g., DEV, CAPA, and CC-cases
  • Execution of equipment and utility qualification
  • Preparation and writing instruction e.g., SOP, WIN etc.
  • Assignment of daily operations according to current plan and priority
  • Handle actions and follow up on audits and inspections

Your 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.

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.

Apply

Contact

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. If you want to know more about the position before submitting your application, please refer your questions to Anne Rosenkilde on telephone +45 6191 1089.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Hørsholm.

Jobbet er oprettet på vores service den 6.3.2023, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Hørsholm

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