Qualification & Validation at Visp

Senior Qualification Specialist (CQV)

Start Date: ASAP

Location: Visp, Switzerland

About the Role

Our client, a leading pharmaceutical and biotechnology company, is seeking a Senior Qualification Specialist to join its team in Visp, Switzerland.

In this role, you will be responsible for supporting commissioning, qualification, and validation activities for GMP-regulated equipment and facilities. You will play a key role in ensuring compliance, operational excellence, and the successful delivery of critical projects within a fast-paced manufacturing environment.

Key Responsibilities

• Develop, review, and maintain Commissioning, Qualification, and Validation (CQV) documentation.
• Execute and approve IQ, OQ, and PQ protocols for critical systems and equipment.
• Lead and support deviation investigations, CAPAs, and Change Control activities.
• Manage equipment and system lifecycle activities following implementation.
• Coordinate qualification activities with internal stakeholders, suppliers, and external service providers.
• Support audits, inspections, and regulatory submissions by presenting qualification documentation.
• Ensure compliance with GMP requirements, internal procedures, and industry best practices.
• Drive continuous improvement initiatives to enhance quality, compliance, and operational efficiency.

Requirements

• Bachelor’s degree or higher in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical field.
• Minimum 5 years of experience in a GMP-regulated environment with a strong background in Commissioning, Qualification & Validation (CQV).
• Experience qualifying process equipment, clean utilities, refrigerators, freezers, and critical GMP systems.
• Solid knowledge of GMP regulations, Change Control, Deviations, Investigations, and CAPA processes.
• Proficiency with MS Office; experience with Kneat, TrackWise, SAP, COMOS, or DMS is considered an advantage.
• Fluent in English; German is a strong asset.
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively within multidisciplinary teams.