Commissioning & Qualification Engineer (C&Q)

Commissioning & Qualification Engineer (C&Q)

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Direct message the job poster from agap2 Switzerland

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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