CQV Engineer – Basel, Switzerland

Leap29 are working with an international EPC company that supports pharmaceutical and biotechnology industry.  Our client is growing their CQV team and looking for engineers to join the on a permanent basis, this position will be involved in the preparation of deliverables and activities during the entire project life cycle, from the engineering phase till the Commissioning and Qualification execution on site.

In this role you should be willing to work on projects in Switzerland & Europe.

Responsibilities:

• Preparation of Validation Plan, Commissioning Plan and project procedures
• Preparation, execution and review of FAT, Commissioning and SAT protocols
• Preparation, execution and review of Qualification protocols (IQ, OQ and PQ)
• Design Review (DR) and Design Qualification (DQ) protocol preparation, execution and follow-up
• GMP Risk Assessment (FMEA)
• Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)
• Review and follow-up the technical documentation from the early design phase in order to align it with GMP and C&Q requirements
• Contractors and Vendors coordination
• Support the preparation of the final reports to the end-user

Requirements:

• Degree or equivalent in an engineering related discipline
• 5+ years of experience in commissioning and qualification activities for pharmaceutical facilities
• Fluent German and English languages required.

Please get in touch if you have any questions or follow the link to apply.