Qualification and validation Engineer

Did you ever want to work for a company placing humans at the heart of its DNA?

Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders?

YES? SO DO WE!

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014, we have delivered outstanding industry expertise and support to our clients across the complete product lifecycle.

Are you passionate about CQV activities and interested in working in highly regulated GxP environments?

Join a team where your expertise will directly contribute to the successful delivery of critical Biopharma manufacturing projects.

To continue successfully supporting our clients, we are currently looking for 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
• Human-sized company with colleagues from diverse cultural and professional backgrounds
• Open and transparent culture where collaboration and feedback are valued
• Opportunity to work on ambitious and innovative Life Sciences projects
• International and multicultural working environment
• Continuous learning and development opportunities
• Competitive compensation package and attractive employment benefits

At GXP Consulting Switzerland, everyone contributes to our collective success and grows individually along the way.

If you share our passion and values, we will be glad to hear from you!