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Process Specialist - Aptio Group Denmark Aps

aptio group Denmark ApS



Process Specialist
Do you have an eye for detail and enjoy working with the latest technology and state-of-the-art equipment in a versatile project team? This could be something for you! The position is based in the Greater Copenhagen area.

Main Responsibilities:

As Process Specialist, you will be the cornerstone of the process engineering team;

  • Design, Specify and install new process equipment and provide technical support and troubleshooting for Cell Culture (Upstream), Purification (Downstream), Clean Utility/CIP and Solution Preparation at specialist level.
  • Manage, provide direction and ensuring a smooth cooperation with engineering providers, vendors, project disciplines and User teams.
  • Reviewing URS’s, technical documents, and validation material. Challenge technical changes and ensure best possible solutions are approved and implemented.
  • Support in development of Design supervision/guidance/review
  • Installation supervision and collaboration with the commissioning team
  • Scoping and implementation of equipment modification
  • Drive changes including performing risk assessments, technical troubleshooting for all purification equipment
  • Review validation protocols and support commissioning and validation testing and perform training to the production teams

Requirements:

  • · Minimum a Bachelor’s Degree within engineering or similar discipline
  • · Fluent in spoken and written English

    · Experience with equipment in a commercial GMP environment

    · Self-driven and curious with a go-do attitude

    · Ability to navigate in complex project settings

    · Experience with project management and risk management

    · A team player but also comfortable working independently

    · 10-15 years of experience in the areas of GMP manufacturing, engineering, or facilities in a pharmaceutical environment

Are you curious to know more about the position, do not hesitate to contact us. All applications must be submitted in English and are treated confidential.

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aptio group Denmark ApS

Krakasvej 17, 1., 3400 Hillerød

Aptio Denmark ApS, rooted in Denmark, is a specialized pharma consultancy in the life sciences arena. We provide expert solutions for a variety of challenges in the pharmaceutical sector, ensuring customized support for our clients. Our strength lies in our collaborative spirit and the diversity of our team, committed to fostering advancements in healthcare through strategic partnerships and innovative approaches.


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