Biotech Validation Engineer - GMP, IQ/OQ (EU/Swiss)

agap2 Switzerland

Bern

Sur place

CHF 110 000 - 160 000

Plein temps

Il y a 2 jours
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Avantages offerts par ce poste

Training with accredited centers
Local management support
Career development potential

Résumé du poste

agap2 is seeking a validated-focused professional to support clients in biotech/pharma projects on site in Switzerland. You will contribute to equipment integration, validation planning, and qualification activities while working within GMP guidelines.

Fluency in German and English, plus a strong background in process validation and equipment qualification, are required. The role offers long-term stability with an established Swiss client base and opportunities for development within a dynamic

Qualifications

  • Experience in process validation and equipment qualification in GMP environment.
  • Understanding of biotechnology production processes (USP, DSP, F&F).
  • Fluent in German and English.
  • Willingness to join a long-established Swiss company with client portfolio.

Responsabilités

  • Contribute to integration of new production equipment and utilities in biotech/pharma environment.
  • Create specifications (URS) and perform risk analyses (FMEA, FRA).
  • Create and review Validation Master Plan (VMP).
  • Develop and write test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements.
  • Assist in commissioning at suppliers (FAT).
  • Assist in commissioning on customer site (SAT).
  • Perform installation and operational tests (IQ/OQ/PQ).
  • Work under supervision of a Lead Validation Engineer.

Connaissances

GMP knowledge
Process validation
FMEA
Equipment qualification
Technical writing
German language
English language

Formation

Engineering degree in biotechnology/pharma

Description du poste

agap2 is seeking a validated-focused professional to support clients in biotech/pharma projects on site in Switzerland. You will contribute to equipment integration, validation planning, and qualification activities while working within GMP guidelines.

Fluency in German and English, plus a strong background in process validation and equipment qualification, are required. The role offers long-term stability with an established Swiss client base and opportunities for development within a dynamic

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