As a (Senior) Consultant Qualification & Validation, you will play a key role in ensuring compliance and quality within the life sciences industry. You will independently manage and execute qualification and validation activities for equipment, utilities, facilities, computerised systems, and processes, ensuring adherence to GxP standards and global regulatory requirements (FDA, EMA, WHO, ISPE GAMP 5). Acting as a primary contact for clients, you will lead projects from planning to completion, provide strategic guidance, and build strong client relationships. This role requires working on-site at client locations across Germany, providing hands-on support and ensuring successful project delivery.
Prepare, execute and document processes validation for Manufacturing, Labelling and Packaging
Manage project timelines, resources and deliverables to ensure successful project execution
Act as the main client contact for validation-related topics, leading client meetings, workshops and project communications
Mentor and support junior team members in validation best practices, documentation standards and regulatory expectations
Lead quality assurance activities within validation projects, ensuring adherence to internal and client-specific quality standards
Support change management activities related to validation projects, helping clients manage regulatory changes and new technologies
Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field
~ 3–5 years of hands-on experience in Validation and Qualification within the Life Science industry (e.g. pharma, biotech, medtech)
~ Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO)
Demonstrated track record in managing client-facing projects, including client communication and relationship management
Advanced knowledge of validation project management methodologies (traditional and agile approaches)
High adaptability to manage change and ambiguity in dynamic project environments
Strong time management skills with the ability to handle multiple validation projects in parallel
Cultural awareness and the ability to work effectively in diverse, international teams
Very good command of English and German