Project Manager Validation Services

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 customers milestones as well as the respective Sartorius technologies. Formulate and execute action plan of how Sartorius technologies and services can help achieve the customers or the projects 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.

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.
Experience:

IC