Project Manager Validation Services
The primary responsibility of this position is to coordinate bioprocess validation projects (including filters, bags, other single-use components, etc) based on customer and regulatory requirements and in line with the Sartorius Stedim validation philosophy for the local market. In addition, project specialist should provide technical consultancy on validation services and support for regulatory affairs activities or projects.
Part 1. Validation Services Support
Validation Services Field Marketing Support
- Customer development and support the consumables business growth via cooperation with sales colleagues and application specialists for cross selling
Management of Validation Projects
- Coordination of validation project on behalf of customer in a timely manner
- Providing technical consultancy and risk assessment
- Preparation of quotation and validation documents in English and Chinese
- Tracking all validation leads and projects via applicable tools
- Monthly summary report
- Optimize all the validation document templates or process flow when necessary
Part 2 Regulatory Affairs Support
- Support regulatory workshops preparation (agenda, materials, invitation, etc.)
- involve into regulatory projects via regulation contents summary, translation and communication.
- Provide customer support on the regulatory requirement or updates.
- Graduate in biotechnology, microbiology, chemistry or equivalent (work experience minimum 3-5 years) with bachelor degree or above
- Previous and proven experience supporting single-use bioprocess validation projects either hands-on or in advisory capacity
- Good understanding of drug manufacturing processes and requirements of pharmaceutical industry related to regulatory compliance and quality (NMPA, FDA, EMA, WHO, etc)
- Experienced with project management and teamwork
- Fluent in English (writing, reading and speaking)
- Good knowledge of Microsoft Office Applications (Word, Excel, PowerPoint)
- Be willing and able to travel (20%-30%)
We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
- Reference Number R4164
- Job Begin July 01, 2021
- Employment Mode Full time
- Position Fixed Term
- Functional Area Marketing
- Location Shanghai (China)