This is your area of ​​responsibility

As Team Lead Process & Validation Science, you will be responsible for the professional and disciplinary leadership of an interdisciplinary team of scientists, validation specialists, and experts in hygiene and environmental monitoring. Together, you will ensure that critical processes, cleanrooms, cleaning procedures, packaging, and sterilization processes are scientifically sound, validated, monitored, and continuously improved.

• Professional and disciplinary management of the Process & Validation Science team, including hygiene and environmental monitoring.
• Further development of scientific and technical skills within the team
• Responsibility for validation strategies in the areas of cleanroom, cleaning, packaging, sterilization and reprocessing of instruments.
• Management of complex validation and requalification projects
• Technical evaluation of deviations, OOS results, trends, CAPAs and changes
• Further development of cleanroom, hygiene and environmental monitoring concepts
• Ensuring the audit and inspection capability of the area of ​​responsibility
• Active participation in the strategic development of Scientific Affairs and the company-wide validation system
• Close collaboration with QA, RA, production, engineering and external service providers

This is what you bring with you

• Education:
  • Completed studies in medical technology, biotechnology, natural sciences, process engineering, pharmaceutical technology or a comparable field
• Professional experience:
  • Several years of professional experience in medical technology, pharmaceutical industry, biotechnology or a similarly regulated industry
• Professional expertise:
  • Solid knowledge in validation, qualification, cleanroom technology, hygiene or microbiology systems or critical manufacturing processes.
  • Experience with risk-based validation approaches, statistical methods, and experimental study designs
  • Excellent knowledge of relevant standards and regulatory requirements, e.g., ISO 13485, ISO 14644, GMP and Annex 1
• Soft skills:
  • Experience in dealing with audits and regulatory inspections
  • Leadership experience or demonstrable experience in the professional management of interdisciplinary teams
  • Strong analytical skills and the ability to present complex relationships in an understandable way.
  • Very good German and English skills