Manager Validierung in einem etablierten Medizintechnik-Unternehmen. Fokus auf Validierungsmanagement und regulatorische Anforderungen, verbunden mit Schulungen und Audits.
Responsibilities
Develop, maintain and advance validation management policies and procedures, including qualification, process validation, computerized system validation (CSV) and method validation
Technically review, approve and support validation activities in development and production
Train employees on validation-related topics
Conduct internal audits and actively support inspections and external audits as a subject-matter expert
Participate in CAPA management, including initiating, implementing and tracking corrective and preventive actions (CAPA)
Requirements
Degree in engineering, natural sciences or a related technical field
Several years of experience in qualification and validation within a GMP-regulated environment, e.g., pharmaceutical or medical device industries
Fluent German (C1) and English skills
Structured working style, strong documentation proficiency and a confident professional manner
Benefits
Opportunity to shape processes in a stable, growth-oriented environment
Flat hierarchies, short decision-making paths and collegial teamwork
Flexible working hours with remote working option
Competitive compensation, company pension plan and additional benefits such as Hansefit and bicycle leasing
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