The Technical Project Manager, Validation Services drives commercial growth and operational excellence by leading customer validation projects, managing customer relationships, and coordinating cross-functional execution to ensure regulatory compliance, customer satisfaction, and business success.
*Management of Validation Projects*
- Understand customer requirements and concerns.
- Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO).
- Provide technical consultancy and risk assessment based on Sartorius Stedim validation philosophy and globally harmonized test methods.
- Preparation of quotes for different test scenarios / scopes.
- Ensure efficient and effective completion of validation projects under consideration of complexity and time in coordination with the sales team, the customer and the validation lab(s).
- Preparation, review and approval of scientific and technical validation documents (statements, protocols,
reports and other documents) in English.
- Track all validation leads and projects via applicable tools and provide monthly summary report.
*Support of sales of Validation Services*
- Promotion of validation services to customers and local markets (workshops, webinars, etc.)
- Support the consumables business growth via cooperation with application specialists for cross selling.
- Customer visits, travel and training (e.g. acquiring new projects, presentation of Validation Services, generating validation leads).
- Role requires minimum of 30% travel with onsite customer and sales visits (e.g. acquiring recent projects, presentation of Validation Services, generating validation leads).
*Regulatory Affairs Support*
- Support preparation of regulatory workshops by providing summaries of relevant regulations and provide customer support on the regulatory requirement or updates.
- Articulate to customers and in projec