CQV Engineer

Commissioning Qualification and Validation Engineer DE/EN (M/F/X)

The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities. The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according to cGMP requirements.

• Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
• The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
• Write reports of completed validation activities. Work to identify efficiencies in the validation program approach. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s. Writing and/or revising procedures applicable to the Engineering activities.
• Support the Engineering group to prepare the validation, requalification, and maintenance program

• Fluent German and English (C1)
• Bachelor’s Degree in Science or Technical field.
• Advanced Level Pharma Industry 5-10 years. With extensive GMP experience.
• Experience with vial and syringe filling & lyophilisation.
• Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
• Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
• Excellent organizational and time management skills.

This is a 100% on-site role.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.