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Principal Validation Engineer – Process and Cleaning Validation

Job ID 1602154 Date posted11/21/2016 LocationBrooklyn Park, Minnesota, United States;
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!

OBJECTIVES:

  • Unique opportunity to be a part of the start of commercial production of Entyvio and other life changing therapeutic monoclonal antibodies at the Brooklyn Park facility
  • The role will develop and implement validation processes to ensure that process validation activities at a multi-product biologics facility meet appropriate regulatory requirements, internal company standards and current industry practices.
  • The role will develop plans, protocols, and reports that support cleaning validation associated with multi-product biologics facility.
  • The role will develop, complete, log and archive validation documentation

ACCOUNTABILITIES:

  • 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.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Minimum of a BS in Sciences/Engineering (other degrees accepted provided the individual has relevant experience.
  • Minimum of 5-8 years’ relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry.
  • Must have prior process validation and cleaning validation experience within biologics manufacturing industry.
  • Proficient in the implementation of FDA and ICH guidelines (Q7, Q8, Q9, Q10, and Q11) as they apply to Process and cleaning Validation in biologics manufacturing.
  • Have excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
  • Familiar/experienced in protein purification from cell culture processes.
  • Understanding of biochemical and microbiological methods supporting the product line.
  • Experience with qualification protocol development and execution.
  • Experience conducting statistical analysis of validation test results.
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficient in Microsoft Word and Excel, Project and other desktop computing software.

PHYSICAL DEMANDS:

  • 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.

TRAVEL REQUIREMENTS:

Less than 15%


we are driven to improve people's lives

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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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Schedule
Full-time