Process Validation Associate / Engineer

Krystal Biotech is seeking a motivated Process Validation Associate (1+ years’ experience) or Engineer (3+ years’ experience) to support process validation planning, design, and execution. The role involves performing risk assessments, process improvements, investigations, and collaborating with CMC and manufacturing teams to ensure process transfer. Krystal specializes in gene therapy treatments and is looking for individuals committed to scientific integrity and continuous improvement.

Requirements

• Partner with Process Development and Manufacturing to ensure upstream and downstream processes are well controlled.
• Apply QbD and traditional process validation principles to existing and new gene therapy products.
• Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding.
• Troubleshoot process and equipment issues to ensure efficiencies in processes.
• Produce high-quality documentation.
• Work on development of new manufacturing facility.

Benefits

• Equal Employment Opportunity