Process Validation Engineer

Employment Type

: Full-Time

Industry

: Engineering



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Responsibilities:
  • Development of process validation protocols and other documentation for cell banking, cell culture and purification processes.
  • Write, execute, analyz490###.####45e results and summariz490###.####45e process validation activities related to tech transfer (new product introduction), change management, and continuous lifecycle management.
  • Develop and assess the following Quality System elements for Process Validation: Quality Risk Management program, CAPAs, Change Controls, Deviations, and GMP Investigations.
  • Participate and contribute in design, development, validation strategy, and routine GMP activities.
  • Provide technical input to strategy/philosophy for validation activities.
  • Represent process validation during tech transfer activities as required.
  • Represent process validation during site GMP activities and participate on cross-functional teams.
  • Own process validation Quality Systems, as required, and manage project through to closure per timelines.
  • Execution of process validation studies, as well as data analysis and compilation of data and results into summary and final reports.
  • Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
  • Own process validation related quality systems (CAPA, Change Control) and use project management skills to coordinate those project teams and drive results.
  • Qualifications & Experience:
  • Bachelor s Degree in Science or related technical field. Master s Degree is also preferred.
  • Minimum of 4+ years of experience in the biotechnology or pharmaceutical industries.
  • Must have demonstrated understanding of cGMP.
  • Strong experience with capital projects is necessary.
  • Proven ability to manage projects while meeting all deliverables and timelines.
  • Excellent written and verbal communication skills

  • Associated topics: bio, biochemistry, bioengineering, biomedical, biophysics, enzyme, fermentation, genetic, metabolic, nutrition

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