Biotech GMP Validation Engineer — On-Site Projects

agap2 Switzerland; Bern; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Career development

Stable position

Training programs

Local management support

Collaborative team

Strong portfolio

Zusammenfassung

agap2 is a European engineering and operational consulting group specializing in biotech, pharma, and life sciences, with a strong Swiss presence.

As a consultant, you will support client projects on site, applying your expertise in process validation, equipment qualification, and GMP compliance.

Fluent German and English are required; the role offers varied projects, on-site deployments, and ongoing professional development.

Qualifikationen

• Engineering degree in biotechnology or related field.
• Experience with process validation and equipment qualification in GMP.
• Understanding of biotech production processes (USP, DSP, F&F) is essential.
• Good Manufacturing Practices knowledge.
• Fluent in German and English.

Aufgaben

• Contribute to integration of new production equipment and utilities in biotech/pharma settings.
• Create specifications (URS) and perform risk analyses (FMEA, FRA).
• Develop and review Validation Master Plans (VMP).
• Create/write test protocols for commissioning and qualification (FAT/SAT/IQ/OQ/PQ) per GMP.
• Participate in commissioning at suppliers (FAT) and at customer sites (SAT).
• Perform installation and operational tests (IQ/OQ/PQ) under supervision.

Kenntnisse

Process validation

Equipment qualification

GMP knowledge

German language

English language

Ausbildung

Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)

Jobbeschreibung

agap2 is a European engineering and operational consulting group specializing in biotech, pharma, and life sciences, with a strong Swiss presence.

As a consultant, you will support client projects on site, applying your expertise in process validation, equipment qualification, and GMP compliance.

Fluent German and English are required; the role offers varied projects, on-site deployments, and ongoing professional development.