Process Validation Specialist

1 day ago

Pittsburgh PA USA, United States Krystal Biotech, Inc. Full time
About Krystal Biotech

Krystal Biotech is a pioneering biotech company that is revolutionizing the field of genetic medicine. With a strong focus on innovation and scientific excellence, we are committed to developing and commercializing genetic medicines to treat diseases with high unmet medical needs.

Job Description

We are seeking a highly motivated and experienced Process Validation Associate to join our team. As a key member of our process development and validation team, you will be responsible for ensuring the quality and integrity of our gene therapy products. Your primary responsibilities will include:

  • Partnering with process development and manufacturing teams to ensure upstream and downstream processes are well controlled.
  • Applying QbD and traditional process validation principles to existing and new gene therapy products.
  • Performing and documenting risk assessments to capture existing process knowledge and to identify gaps.
  • Performing experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development.
  • Troubleshooting process and equipment issues to help ensure efficiencies in processes.
  • Helping to implement a continuous improvement mindset to processes and departments.
  • Producing high-quality documentation that meets applicable standards and is appropriate for its intended use.
  • Working on the development of new manufacturing facilities to ensure proper transfer of technology and processes.
  • Working with CMC counterparts to draft materials intended for agency review.
Requirements

To be successful in this role, you will need:

  • A Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or a related field.
  • Relevant validation and/or engineering experience in the biotech or pharmaceutical industry (1+ year for Associate, 3+ years for Engineer level).
  • Background that includes knowledge/experience in GMP, GLP, and statistics.
  • Strong knowledge of GMP and ICH requirements and QbD.
  • Prior experience in the gene therapy field is desired.
  • You must be a self-starter and capable of working with minimal oversight.
  • You must be able to handle multiple roles and work in a fast-paced and changing environment and know how to prioritize activities appropriately.
  • Excellent oral and written communication skills.
About Krystal Biotech, Inc.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. We are committed to diversity and inclusion in the workplace and are proud to be an employer of choice for talented individuals from diverse backgrounds.

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