Qualification Engineer

vor 1 Tag

Basel, Basel-Stadt, Schweiz agap2 Switzerland Vollzeit

agap2
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.

Your Mission

Become a key player in a
brand-new greenfield project
where you will help build, qualify, and launch state-of-the-art production and packaging lines from the ground up. This is your chance to shape an entire facility's future in a high-growth biotech/pharma/medtech environment.

You will take part in every critical stage of bringing new systems to life:

  • Define technical expectations by developing
    high-impact URS
    and performing
    comprehensive risk analyses
    (FMEA, FRA)
  • Lead the creation and review of the
    Validation Master Plan (VMP)
    for newly installed equipment, utilities, and production areas
  • Design, write, and optimize qualification and commissioning protocols (
    FAT/SAT/IQ/OQ/PQ
    ) for new production lines, new packaging lines, and new utilities under strict
    GMP/MDR requirements
  • Actively participate in
    FAT/SAT
    at supplier sites and on-site to ensure flawless equipment delivery and readiness
  • Execute and document
    IQ/OQ/PQ
    activities to qualify all new systems and guarantee GMP-compliant startup
  • Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence

Your Profile – Ready to Build What Doesn't Exist Yet

You are motivated by large-scale challenges and the opportunity to design, qualify, and launch systems in a completely new facility.

You bring:

  • A degree in biotechnology, pharmaceutical sciences, process engineering, or a PharmD with an industrial focus
  • Solid experience in
    GMP process validation
    and
    equipment qualification
  • A strong command of
    Good Manufacturing Practices
  • Fluency in
    German and English
  • Swiss or EU citizenship

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