Team Lead Process & Validation Science (m/w/d)
Core
Lead an interdisciplinary team of scientists and validation specialists to scientifically develop, validate, monitor, and continuously improve critical processes, cleanrooms, cleaning procedures, packaging, and sterilization processes for medical devices.
Role type
Senior Team Lead Process & Validation Science
Builds
Validated and qualified manufacturing processes, cleanroom environments, and sterilization systems for medical devices
Domain
Medical device manufacturing / Regulatory compliance
Required skills
Team leadership, validation strategy development, cleanroom technology, hygiene and microbiology systems, risk-based validation approaches, statistical methods, experimental study design, regulatory standards knowledge (ISO 13485, ISO 14644, GMP, Annex 1), audit and inspection management
Preferred skills
Experience in regulated industries (medical technology, pharma, biotechnology), strategic development of scientific affairs
Technologies
ISO 13485, ISO 14644, GMP, Annex 1 (via careerplan.io/jobs/2824491-team-lead-process-validation-science-mwd-at-waldemar-link-gmbh-co-kg)
Responsibilities
Provide technical and disciplinary leadership for the Process & Validation Science team, develop validation strategies for cleanrooms, cleaning, packaging, and sterilization, steer complex validation and requalification projects, evaluate deviations and OOS results, develop cleanroom and hygiene concepts, ensure audit readiness, collaborate with QA, RA, production, and external service providers
Seniority
Senior, hands-on IC with team leadership