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 new 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 projects the regulatory framework as relevant to both the customer’s milestones as well as the respective Sartorius technologies. Formulate and execute action plan of how Sartorius technologies and services can help achieve the customer’s or the project’s regulatory goals.
Perform Regulatory surveillance on topics covered by the validation services such as leachables/extractables, validation of single-use systems, analytical methods, acceptance limits.
What will convince us:
Minimum 6 -12 years experience in Validation Services, Filtration or life science industry.
Previous and proven experience supporting single-use bioprocess validation projects either hands-on or in advisory capacity preferred.
Knowledge on the concept of Extractables / Leachable and related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS is a plus
Good understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.)
Familiar with concept of GMP and GDP (Good Documentation Practices)
Experienced with Project Management and Teamwork in global environment
Familiar with concept of GMP preferred.
Excellent knowledge of Microsoft Office applications (Word, Excel, PowerPoint).
Proactive networking with customers and internal stakeholders.
Team-oriented, engaging, and positive attitude towards internal and external stakeholders.
Desire and willingness to learn and progress own and the teams’ knowledge base.
Self-sufficient, target oriented, and self-motivated work style with a positive attitude toward change and continuous improvement.
