System supporter for electronic validation

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Kalundborg

[xxxxx] is expanding its manufacturing facilities in Kalundborg to support the portfolio within chronic diseases. We are hiring a System supporter for electronic validationfor this project – also called the PPV. The activities will take place at our Kalundborg site, which is [xxxxx]'s hub for API manufacturing. Are you interested in being a part of a dynamic global company and working on an exciting new project for capacity expansion? This opportunity involves establishing new active pharmaceutical ingredients (API) manufacturing facilities that integrate new and automated technologies with strong expertise in biotech manufacturing. Apply today and join us for a life-changing career! The position As System supporter for electronic validation,you will be part of the overall project quality team setting the direction within quality for the new API production facilities. You will be the first line support to the local PPV TIMS users during testing (verification) activities. TIMS (Test Information Management System) is a [xxxxx] test and validation tool based on ALM client. Your main tasks will be:
  • Participate in setting the direction on execution of validation testing activities in TIMS
  • Support all verification activities in TIMS (for science and risk-based validation and IT-validation) across the PPV project
  • Administrate our local TIMS database (administer users and the set-up of the database)
  • Perform classroom trainings for new PPV TIMS users
  • Support set-up and roll out of new initiatives and systems related to TIMS
  • Responsibility for coordinating the TIMS super user network
  • Knowledge sharing among members to enhance collaboration and engagement
  • Furthermore, as System supporter for electronic validationyou will represent PPV in relation to corporate TIMS activities.
    Qualifications We are seeking candidates who fulfil the following prerequisites:
  • You have a technical education e.g. Labtech, Bioanalytics, Production Technician or similar technical AP degree educations within IT solutions, pharmaceutical or engineering sciences
  • At least 2 years if experience within GMP and pharmaceutical (API) manufacturing
  • Proven, minimum 3 years of experience working with IT solution supporting validation (preferably TIMS or ALM client)
  • Good understanding of project and validation activities within the pharmaceutical industry
  • Strong communication skills with English and Danish proficiency (verbally and written).
  • As a person you have a high-quality mindset and a structured as well as a proactive approach . You can balance requirements against the progress of project activities. You enjoy teamwork and are a strong motivator of others. You are innovative and thrive in a multicultural environment that demands independence to make critical decisions, and you enjoy simplifying wherever simplicity can benefit reaching the goals faster.
    About the department You will join Purification Plant V (PPV) in Kalundborg, Denmark. We are a team of approximately 250 colleagues, working across several departments and teams to finalize the first process line, which will begin operations this year. We will produce future products for [xxxxx], playing a key role in [xxxxx]’s social responsibility strategy. Our work supports the delivery of significant quantities to third-world countries. We are dedicated to delivering strong results that contribute to [xxxxx]’s success by ensuring high-quality APIs at a competitive cost for our patients. We maintain a relaxed tone, set high ambitions, and take pride in never compromising on quality or safety. You and your team will play a key role in the success of PPV and PPV Business Support. Working at [xxxxx]
    At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
    For further information, please contact hiring manager Kate Timm Hansen, at phone +[xxxxx] Deadline
    6 March 2025 We care about your motivation, but you do not need to att ach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

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

    Arbejdsstedet er beliggende i Kalundborg.

    Jobbet er oprettet på vores service den 20.2.2025, 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
    • Kalundborg

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