Qualification and validation Engineer

We are seeking a Qualification & Validation Engineer to support commissioning, qualification, and validation activities across Biotech and Pharmaceutical manufacturing environments in Switzerland.

• Support Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, process systems, and GMP utilities
• Participate in qualification phases including FAT, SAT, IQ, OQ, and PQ execution
• Coordinate activities between Engineering, Manufacturing, Automation, Quality, and external vendors
• Author, review, and execute qualification documentation including risk assessments, protocols, and summary reports
• Support qualification of systems related to upstream, downstream, aseptic processing, utilities, and process manufacturing
• Ensure activities are performed in compliance with GMP requirements and internal validation standards
• Support deviation management, investigations, CAPAs, and change controls linked to qualification activities
• Contribute to commissioning readiness, project timelines, and continuous improvement initiatives
• Collaborate with cross‑functional teams in fast‑paced project environments

• Engineering degree or equivalent experience in Life Sciences, Biotechnology, Chemical, Mechanical, or related field
• Minimum 5 years of experience in CQV within Pharmaceutical or Biotech environments
• Strong experience with process equipment qualification and GMP utilities
• Exposure to upstream, downstream, aseptic manufacturing, clean utilities, HVAC, or process systems
• Good understanding of GMP regulations, validation lifecycle, and risk‑based qualification approaches
• Experience working in project‑based and multidisciplinary environments
• Strong communication, coordination, and problem‑solving skills
• Fluent in German and English;
  French is a plus

• Competitive compensation package and attractive employment benefits
• Continuous learning and development opportunities
• International and multicultural working environment
• Opportunity to work on ambitious and innovative Life Sciences projects