Biotech Process Validation Specialist

3 weeks ago


Pittsburgh, Pennsylvania, United States Krystal Biotech, Inc. Full time

We are seeking a highly skilled Biotech Process Validation Specialist to support process validation planning, design, and execution at Krystal Biotech, Inc. This individual will be responsible for risk assessments, process improvements, investigations, and other projects in the gene therapy field.

Key Responsibilities:

  • Partner with cross-functional teams to ensure upstream and downstream processes are well controlled.
  • Apply Quality by Design (QbD) principles to existing and new gene therapy products.
  • Perform and document risk assessments to capture existing process knowledge and identify gaps.
  • Conduct experiments (bench scale and manufacturing scale) to close gaps in process understanding and support process development.
  • Troubleshoot process and equipment issues to ensure efficiencies in processes.
  • Implement a continuous improvement mindset to processes and departments.
  • Develop high-quality documentation that meets applicable standards and is appropriate for its intended use.
  • Collaborate with colleagues to develop new manufacturing facilities and ensure proper transfer of technology and processes.
  • Work with regulatory counterparts to draft materials intended for agency review.

Requirements:

  • Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or related field.
  • Relevant validation and/or engineering experience in the biotech or pharmaceutical industry (1+ year for specialist, 3+ years for manager level).
  • Background in GMP, GLP, and statistics.
  • Strong knowledge of GMP and ICH requirements and QbD.
  • Prior experience in the gene therapy field is desired.
  • Must be a self-starter and capable of working with minimal oversight.
  • Must be able to handle multiple roles and work in a fast-paced environment.
  • Excellent oral and written communication skills.

Estimated salary range: $80,000 - $120,000 per year.



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