Commissioning & Qualification Engineer (C&Q)

agap2 Switzerland; Basel; Vor Ort; CHF 70’000 - 90’000; Vollzeit

Zusammenfassung

A leading engineering consulting group in Switzerland is seeking a Commissioning & Qualification Engineer. Your role involves supporting the integration of new production equipment and performing validations in compliance with GMP standards. The ideal candidate holds an engineering degree and has experience in the pharmaceutical sector.

Qualifikationen

• Engineering degree in relevant fields required.
• Experience in GMP environments essential.
• Knowledge of specifications and risk analysis.

Aufgaben

• Support integration of new production equipment in biotech/pharma environments.
• Create specifications and perform risk analyses.
• Write and review test protocols for qualification.

Kenntnisse

Process validation

Equipment qualification

Good Manufacturing Practices

Fluent in German

Fluent in English

Ausbildung

Engineering degree in biotechnology, pharmaceutical sciences, process engineering, or industrial pharmacy

Jobbeschreibung

Commissioning & Qualification Engineer (C&Q)

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Specialist in hiring engineers, pharmacists, and business managers for Life Science in Switzerland!

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

As a consultant, you will support our clients in project realization on-site by applying your expertise and skills.

You are adaptable and eager to work in different environments, fueling your curiosity about major projects in our clients' portfolios.

Your missions:

• Support the integration of new production equipment and utilities in biotech/pharma/medtech environments.
• Create specifications (URS) and perform risk analyses (FMEA, FRA).
• Develop and review the Validation Master Plan (VMP).
• Write and review test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ, in accordance with GMP/MDR requirements.
• Perform installation and operational tests (IQ/OQ/PQ).

Your profile:

• Engineering degree in biotechnology, pharmaceutical sciences, process engineering, or industrial pharmacy (PharmD).
• Experience in process validation and equipment qualification within a GMP environment.
• Knowledge of Good Manufacturing Practices.
• Fluent in German and English.
• Swiss or EU citizenship.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Engineering, Science, and Quality Assurance

Industries

• Engineering Services, Pharmaceutical Manufacturing, Biotechnology Research

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