Public summary
A leading biotechnology company in Bergisch Gladbach seeks a Qualification Validation Expert to support the transition from clinical to commercial manufacturing of cell and gene therapies. The role focuses on ensuring GMP compliance through qualification, validation, and lifecycle management of production, quality control, and logistics systems. Candidates with a background in Life Sciences, Biotechnology, or comparable qualifications, and initial experience in GMP-regulated environments, especially with IQ/OQ/PQ activities, are encouraged to apply. The position offers flexible and remote work options, a diverse and international team environment, and opportunities for professional development.
Location and work setup
- Location
- Bergisch Gladbach
- Remote status
- Hybrid
- German requirement signal
- No German Required Detected
- Detected job language
- English
Responsibilities
Support qualification, validation, and lifecycle management activities for manufacturing equipment, utilities, and laboratory systems within a GMP manufacturing site. Execute and document IQ/OQ/PQ activities ensuring system qualification compliance. Prepare, maintain, and update related qualification and validation documentation, including URS, risk assessments, test plans, reports, and SOPs. Collaborate on qualification and validation projects, implement compliant solutions, and assist with GxP-related activities such as deviations, CAPAs, and change controls. Support continuous process improvement efforts in a multidisciplinary setting.
Qualifications
Degree in Life Sciences, Biotechnology, or related discipline, or qualification as a Biological Technical Assistant (BTA) or comparable. Initial experience with qualification, validation, commissioning, or IQ/OQ/PQ activities in GMP environments. Knowledge of GMP requirements and experience in pharmaceutical, biotechnology, medical device, or regulated industries is advantageous. Strong organizational skills, structured working style, and a proactive approach to process improvements. Excellent communication skills with fluency in English and ability to work effectively in cross-functional international teams.