Validation Project Specialist
An internationally renowned biotechnology company is seeking to recruit a Validation Project Specialist to their office in Shanghai. The organisation provides cutting-edge products and services for the development, quality assurance, and production processes of the biopharmaceutical industry, covering fermentation, cell cultivation, filtration, purification, fluid management, and lab technologies. This position is an exciting opportunity to work with an innovative and prestigious establishment that is strongly rooted in the scientific community.
- Promote validation services to local market (workshops, webinars, etc.).
- Support the consumables business growth via cooperation with application specialists for cross selling.
- Perform customer visits, travel, and training (e.g. acquiring new projects, presentation of Validation Services, and generating validation leads).
- Understand customer requirements and concerns
- Coordinate validation projects on behalf of customers in a timely manner, according to the agreed test scenario as well as in compliance with regulatory requirements (CFDA, FDA, EMA, WHO, etc.).
- Provide technical consultancy and risk assessment based on company validation philosophy and globally harmonised test methods.
- Prepare quotations for different test scenarios/scopes.
- Ensure the completion of validation projects effectively under consideration of complexity and time advised via coordination with sales team, customer, and validation lab.
- Prepare, review, and approve scientific and technical validation documents (statements, protocols, reports, and other documents) in English and Chinese.
- Track all validation leads and projects via different tools and provide monthly summary report of validation services.
- Optimise all the validation document templates or process flow when necessary.
- Support regulatory workshops preparation (agenda, materials, invitation, etc.) and become involved in regulatory projects via regulation contents summary, translation, and communication.
- Provide customer support on the regulatory requirement or updates.
- Formulate and execute action plans of how company technologies and services can help achieve the customer's or the project's Regulatory goals.
Skills and Requirements:
- Graduate in biotechnology, microbiology, chemistry, or equivalent with at least a Bachelor's degree.
- A 3-year minimum of work experience.
- Previous and proven experience supporting single-use bioprocess validation projects either hands-on or in advisory capacity
- A good understanding of drug manufacturing processes and requirements of pharmaceutical industry related to regulatory compliance and quality (CFDA, FDA, EMA, WHO, etc).
- Familiar with GMP and GDP.
- Fluent in English (writing, reading and speaking).
- Be willing and able to travel (30%-40%).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.