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Holbæk

    Senior consultant for a newly established QC/IPC/Lab. Team - Holbæk, Danmark - Al Engineering A/S

    Al Engineering A/S
    Al Engineering A/S Holbæk, Danmark

    for 6 dage siden

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    Fuldtid
    Beskrivelse

    Senior consultant for a newly established QC/IPC/Lab. Team

    AL Engineering A/S – Partner of Consultys - provides medical device & pharmaceutical industry with consulting services that fulfil our clients' internal goals while complying with regulations and industry GMP practice. It is our job to maintain cutting-edge knowledge of current and impending FDA and EU regulations and industry trends so that we can keep our clients savvy of these unique industries.

    Job Summary

    Come and join our newly established business unit which will specialize in QC, IPC and laboratory equipment and facilities. As part of the team, you will support customers within the Pharmaceutical/biotech industry to renovate, expand or establish new facilities typically associated with their manufacturing facilities.

    In this role, you will utilize your knowledge and experience with Quality Control, In Process Control and laboratory equipment. Since you will generate test packages, coordinate, and execute commissioning and qualification processes, and provide operational expertise, it important that you enjoy working with technical issues related to all sort of equipment that can be found in QC, IPC, and laboratory environments.

    We are looking for a new colleague with profound knowledge within pharmaceutical/biotech industry that can expand and grow the business. You will among other be responsible for procuring new clients and maintaining a long-term relationship with well customers. Based on your knowledge you will be participating in ongoing projects or managing your own.

    We imagine that you have a solid technical background, engineer or relevant master's degree and an industry track record as a consultant, project manager or similar. It will be a plus if you can show a track record of procuring projects and clients, and you have a network to provide evidence for this.

    Responsibilities:

  • Generate commissioning and qualification test packages or support others in generating respective documents. Coordination and execution of commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ)
  • Carry out the commissioning and qualification within a laboratory and/or plant environment. Including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP)
  • Create test plans for qualification, support and cooperation with QA
  • Regularly reports the status of assigned work
  • Brings operational experience during the commissioning and qualification phase
  • Support automation engineers with operational know-how

    Requirements:
  • Minimum 5 years of experience in commissioning and qualification of equipment in pharmaceutical/biotech manufacturing or laboratory facilities
  • Hands-on experience with QC, IPC and/or laboratory activities, equipment and operational experience
  • Good GMP skills for completing qualification documentation
  • Be outgoing, energetic have a pioneering spirit
  • Be service minded and a good listener
  • Be able to work both independently and in a team, and have a self-motivated personality

  • Have excellent communication skills, in writing and orally in Danish and English

    Additional information about the position can be obtained from Allan Povlsen (phone: Applications are processed successively. Attach short application and CV documents to -
    Working as a consultant at AL Engineering is a diversified and challenging job. The job often needs high flexibility and ability to adapt to changing tasks, environments, and cultures. We make our living by providing solid services and knowledge to our customers. Tasks can be simple or complicated, but they must all be performed with the same level of commitment and quality. We offer a professional working environment where there is an opportunity to work with talented colleagues. Furthermore, there is ample opportunity for professional development and qualification.

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