CQV Engineer

For our partner located in the canton of Valais, GI Life Science is looking for a: CQV Engineer

Temporary position

Your Mission:

The CQV (Commissioning, Qualification, Validation) Engineer performs tasks related to the validation of equipment and facilities. This includes coordinating equipment installation, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting the results in compliance with GMP requirements.

Your Responsibilities:

• Participate in all validation activities (facilities and utilities, validation life cycle, execution and technical documentation, process, gap analysis, risk assessment).
• Validation deliverables include: URS (User Requirements Specification), DQ (Design Qualification), FMEA (Failure Mode and Effects Analysis), FAT/SAT (Factory and Site Acceptance Testing), and IQ, IOQ, OQ, PQ protocols.
• Prepare validation documentation.
• Execute IQ/OQ/PQ for equipment, systems, and utilities.
• Write reports on completed validation activities.
• Participate in Quality System activities: document management, change control, non-conformities, and CAPAs.
• Write or revise procedures related to engineering activities.
• Support the engineering team in preparing validation, requalification, and maintenance programs.

Your Profile:

• Minimum Bachelor’s degree in a scientific or technical field.
• Fluent in German and English.
• Experience in the pharmaceutical industry.
• 5 to 10 years of experience in a similar position.