Validation Engineer - Life Sciences (Biotech/GMP)

agap2 Switzerland; Bern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Strong development potential

Established in Switzerland with major,

Career development opportunities

Accredited training centers

Local management support

Dynamic, values-driven team

Zusammenfassung

agap2 is a European engineering and operational consulting group with a long-standing Swiss presence, seeking a consultant to support clients on site in biotech/pharma projects. The role emphasizes validation, testing, and commissioning within GMP environments.

The ideal candidate holds an engineering degree in biotechnology/pharma/process engineering (PharmD) and has hands-on experience in process validation, equipment qualification, and GMP practices, with fluent German and English.

Qualifikationen

• 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).
• Good Manufacturing Practices (GMP) compliance.

Aufgaben

• Contribute to integration of new production equipment and utilities in biotech/pharma environment.
• Create specifications (URS) and risk analyses (FMEA, FRA).
• Create and review the Validation Master Plan (VMP).
• Write and review test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ per 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 supervision of a Lead Validator.

Kenntnisse

German language

English language

GMP knowledge

Ausbildung

Engineering degree in biotechnology/pharma/process engineering/PharmD

Jobbeschreibung

agap2 is a European engineering and operational consulting group with a long-standing Swiss presence, seeking a consultant to support clients on site in biotech/pharma projects. The role emphasizes validation, testing, and commissioning within GMP environments.

The ideal candidate holds an engineering degree in biotechnology/pharma/process engineering (PharmD) and has hands-on experience in process validation, equipment qualification, and GMP practices, with fluent German and English.