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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.
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, review and approval of scientific and technical validation documents (statements, protocols, reports and other documents) in English.
Preparation of quotes for different test scenarios / scopes.
Track all validation leads and projects via applicable tools and provide monthly summary report.
Be responsible for the assigned targets to support sales target achievement in the defined territory
Provide technical support proactively, answer inquiries and resolve implementation problems in the field for customers
Provide basic technical training to internal sales and dealers, and running external customer workshops and seminars
Support the consumables business growth via cooperation with application specialists for cross selling.
Role requires minimum of 30% travel with onsite customer and sales visits (e.g. acquiring new projects, presentation of Validation Services, generating validation leads).
Qualification & Skills:
Min of 6 - 10 years experience with academic degree in Biochemistry, biotechnology or other related analytical fields
Understanding on GMP and regulatory topics
Hands-on knowledge on extractable and leachables with related analytical techniques like HPLC, GC-MS, LC-MS, ICP-MS is a must.
Proven experience in a similar position and industry is advantageous
Familiar with final container stability studies and extractable & Leachables is a plus
Strong learning ability, and expert knowledge base in this area
Ability to effectively interface with product / project / division management
Excellent communication and presentation skills
Strong customer orientation
Proven software skills, e.g. Microsoft Office
Fluent in English and ideally in other local languages
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers