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Validation Specialist

vor 2 Monaten


Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit
About agap2 - HIQ Consulting

We are a European engineering and operational consulting group founded in 2005, specializing in various industries including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.

As a trusted partner, we support our clients in achieving their project goals by providing expert advice and skills.

Our team is agile and adaptable, with a passion for delivering high-quality results in diverse work environments.

Key Responsibilities
  • Contribute to the integration of new production equipment and utilities in a biotech/pharma environment
  • Create specifications (URS) and risk analyses (FMEA, FRA)
  • Develop and review the Validation Master Plan (VMP)
  • Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements
  • Participate in commissioning at suppliers (FAT)
  • Participate in commissioning on customer site (SAT)
  • Perform installation and operational tests (IQ/OQ/PQ)
  • Work under the supervision of a Lead Validation
Requirements
  • Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)
  • Experience in process validation and equipment qualification in a GMP environment
  • Understanding of biotechnology production processes (USP, DSP, F&F) essential
  • Good Manufacturing Practices
  • Fluent in German and English
Benefits
  • Join a group with strong development potential, aiming to enhance your employability on challenging and varied projects
  • Be part of a structure established in Switzerland for a long time, with a client portfolio including leaders in the sector
  • Enjoy a sustainable job with stability and access to real collaboration
  • Benefit from training with accredited and certified centers
  • Have a local management team to support you in achieving your missions and developing your career
  • Be part of a dynamic, committed team with real human values that we live by every day

Only applications from Swiss and EU citizens will be considered.