Principal Validation Engineer – Process and Cleaning ValidationApply Now Job ID 1602154 Date posted11/21/2016 LocationBrooklyn Park, Minnesota, United States;
- 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
- 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:
- 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.
- 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.
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