Qualification Engineer

We are a pioneering company in the field of gene therapies, committed to manufacturing safe, efficacious, and scalable products. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation.

We are seeking a highly skilled and motivated individual to join our team as a Qualification Engineer. As a key member of our team, you will be responsible for equipment, computer system, and facility qualification projects, as well as the execution of commissioning and qualification documents for equipment and systems.

• Lead and provide expertise in all equipment qualification matters.
• Develop user and design specifications for equipment and systems.
• Author qualification/validation plans, traceability matrices, test protocols (IQ/OQ/PQ), and summary reports.
• Execute equipment and system testing, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Review and approve lifecycle documentation related to commissioning, qualification, and validation.
• Conduct and oversee computerized system validation for GMP equipment, ensuring compliance with GxP, 21 CFR Part 11, and related regulations.
• Manage and document calibration, qualification, and maintenance activities, ensuring continuous compliance and operational readiness.
• Develop and execute a preventive maintenance program to optimize equipment performance and minimize downtime.
• Troubleshoot and diagnose equipment failures, swiftly determining root causes and implementing corrective actions.
• Investigate deviations and safety issues, utilizing problem-solving methodologies to resolve and prevent future occurrences.
• Conduct risk assessments and develop mitigation strategies for engineering and maintenance activities.
• Participate in regulatory audits to ensure compliance with relevant regulations and standards.
• Author and maintain SOPs and work instructions for QC equipment.
• Coordinate external maintenance and repairs for QC equipment.
• Regularly review audit trails to ensure compliance with data integrity standards.
• Provide training and support to QC personnel on equipment use and troubleshooting procedures.
• Uphold GMP principles and ensure data integrity throughout all processes.

• Bachelor's degree in Life Science/Engineering/Analytical Chemistry or related field and 5+ years of experience in a regulated industry.
• Strong experience with qualification of analytical equipment.
• Experience with validation of GMP computerized systems.
• GMP expertise (especially Annex 15) and good understanding of working in a regulated environment.
• Proactive mindset.
• Good team working spirit.
• Fluent in English and German.
• Good knowledge of Microsoft Office.
• Ability to adapt to changing priorities effectively and work in a start-up environment.
• Strong communication skills and ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• Strong problem-solving skills.

• Company shares.
• 30 days holiday.
• Performance-based bonus.
• More to come as we grow.

We at Ascend Advanced Therapies are committed to diversity and do not tolerate discrimination. We look forward to receiving applications from individuals who align with our vision and values.