Paid Expenses: All travel expenses, flights and housing accommodations
VTI Pharmaceutical Technologies (Shenzhen) Co., Ltd. ( www.vtipharma.cn ) is a multi-national contract validation service provider committed to providing our global clients with the highest quality validation services. VTI Pharma is currently looking for an experienced Process Validation Lead relative to the Biotech/Biopharmaceutical industries. This is a strategic and dynamic role within our global organization.
Validation Technologies, Inc. offers competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
The Process Validation Lead will:
- Perform Risk assessments
- Write Process Validation Master Plan
- Support the development of manufacturing process
- Write process validation protocols
- Support protocol execution
- Support training of staff
- Write final reports for Cleaning Protocols
- Identify, design, and implement validation strategy optimization improvements
- Apply advanced theory, technical principles, and expert judgment to address deviations to validation protocols
- Able to lead small team of people during field execution of validation activities.
- Aseptic Processes
- Cell culture
- Hold time studies
- B.A. or B.S. degree (preferably in Life Science) and a minimum of 5+ years of Process Validation experience in the biopharmaceutical industry prefer Biological vaccine but not a requirement,
- Knowledge of cGMPs or equivalent regulations
- Must have knowledge if and proficiency in the general validation and engineering standards and practices for designing, implementing and supporting manufacturing processes
- Knowledge of risk based principles
- Ability to interpret and relate Quality standards for implementation and review
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving, providing direction and work hours to meet business objectives
- Project Management experience is preferred but not required.
- Automation validation is a plus
All project assignments are for 6 months to year. Travel requirements are 2 – 3 month at project jobsite (Beijing) with 2 weeks back to home base (USA). Western style apartments, daily per-diem and economy flights will be provided.
All candidates are required to:
- work in dynamic team environment
- provide training
- work independent
- team player
- strong communicated skill
- track and manage their budget and task schedule
- strong writing skills
Validation Technologies Offers:
As one of the leading global Commissioning, Qualification, Automation, IT and Validation Services organizations, VTI is always looking for innovative, talented and experienced technical professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
Validation Technologies, Inc - 6 months ago