More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. As a global, research and development-driven pharmaceutical company, Takeda Pharmaceutical Company Limited conducts R&D both internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology and central nervous system, plus vaccines. Novel products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
- This role will represent the validation group in supporting programs for process and cleaning validation.
- Define Process validation strategies and provide leadership through the implementation of Process validation plans and procedures required for a biologics manufacturing facility.
- Lead and perform variety of projects/studies in areas of Process and Cleaning validation to get the facility ready for commercial manufacturing. Work with other functional areas to coordinate process and cleaning validation activities.
- Ability to read/interpret process development and characterization documents.
- Working knowledge of biologics manufacturing process (e.g. cell culture purification process) and associated regulatory requirements
- Ensure cleaning program remains in a validated state and execute periodic cleaning re-validations.
- Review and interpret data for accuracy of cleaning process performance for completed validations/re-validations, and summarize data to support cleaning validation requirements.
- Ability to manage multiple activities while maintaining a high level of organization.
- Ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Supporting regulatory submissions and regulatory agency inspections as required for process and cleaning validation.
- Mentor junior staff in their job performance and project related activities.
- Supporting development of best demonstrated practices within the validation department, based on current industry practices and regulatory guidelines.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- In general, the position requires a combination of sedentary work and walking around the cGMP manufacturing facility.
May occasionally work in a clean room environment and wear special garments and personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
Less than 15%
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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