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 current 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 stud