Company Description
For 35 years, we have been developing innovative medical devices to empower biomedical research and advance medical treatments. This is how we are pushing the boundaries of cell and gene therapy and personalized medicine.
To realize our vision we combine sophisticated research with advanced engineering solutions in agile software development, data science, internet of things, artificial intelligence and connectivity. Today, more than 4,700 experts from over 50 countries contribute to breakthrough innovations and sustainable success.
Job Description

In this role, you’ll be a key member of our Qualification & Validation Team, specializing in the validation of computerized systems. Your work will ensure our systems meet the highest quality standards—playing a vital part in our mission to advance cancer treatment and make a lasting difference in patients’ lives.

• You’ll plan, coordinate, and execute CSV tasks in manufacturing, quality control, and logistics at our GMP-certified site in Bergisch Gladbach.
• From URS and risk assessments to IQ/OQ protocols, reports, and SOPs—you’ll handle all documentation with precision and care.
• You’ll guide departments through validation projects, propose effective solutions, and oversee their implementation.
• As a GxP expert, you’ll be involved in deviation handling, CAPA, change control, and continuously improve validation-related procedures.
• You’ll work closely with internal stakeholders (IT, QA, QC, Manufacturing) and external vendors, and deliver training based on your activities.

QUALIFICATIONS

• You have a degree in life sciences, bioinformatics or engineering and have extensive professional experience in the validation of computerised systems (CSV) as well as solid knowledge of data integrity.
• You are familiar with the requirements of regulated environments in the pharmaceutical industry and are familiar with standards such as GMP and FDA guidelines.
• You love bringing order to complex processes, enjoy working in a structured manner and develop creative approaches to continuously improve processes.
• You are a true team player with strong communication skills – whether interacting with internal teams, customers or external suppliers.
• You enjoy working in an interdisciplinary and international environment, speak fluent English (German is a plus) and feel comfortable in collaborative, cross-functional teams.
  Additional Information

• You’ll plan, coordinate, and execute CSV tasks in manufacturing, quality control, and logistics at our GMP-certified site in Bergisch Gladbach.
• From URS and risk assessments to IQ/OQ protocols, reports, and SOPs—you’ll handle all documentation with precision and care.
• You’ll guide departments through validation projects, propose effective solutions, and oversee their implementation.
• As a GxP expert, you’ll be involved in deviation handling, CAPA, change control, and continuously improve validation-related procedures.
• You’ll work closely with internal stakeholders (IT, QA, QC, Manufacturing) and external vendors, and deliver training based on your activities