Process Validation Specialist

3 months ago


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

Krystal Biotech is a pioneering genetic medicine company that leverages its proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. With a strong focus on patient-centricity, the company is committed to delivering innovative treatments that address high unmet medical needs.

As a Process Validation Associate, you will play a critical role in supporting the development and implementation of process validation strategies for our gene therapy products. This includes collaborating with cross-functional teams to ensure upstream and downstream processes are well-controlled, applying QbD and traditional process validation principles, and performing risk assessments to identify gaps in process understanding.

Key Responsibilities:

  • Partner with Process Development and Manufacturing to ensure seamless process transitions.
  • Develop and execute process validation plans, including risk assessments and process improvements.
  • Collaborate with CMC counterparts to draft materials for agency review.
  • Implement a continuous improvement mindset to drive process efficiency and effectiveness.
  • Develop and maintain high-quality documentation that meets applicable standards.

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 Associate, 3+ years for Engineer level).
  • Strong knowledge of GMP and ICH requirements, as well as QbD principles.
  • Excellent communication and collaboration skills, with the ability to work effectively in a fast-paced environment.

Krystal Biotech is an Equal Employment Opportunity and Affirmative Action Employer.

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