Process Validation Associate / Engineer

About the role

Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site.

Primary Responsibilities

• 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 and document risk assessments to capture existing process knowledge and to identify gaps.
• Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development.
• Troubleshoot process and equipment issues to help ensure efficiencies in processes.
• Help implement a continuous improvement mindset to processes and departments.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
• Work on development of new manufacturing facility to ensure proper transfer of technology and processes.
• Work with CMC counterparts to draft materials intended for the agency review.

Minimum Qualifications & Desired Competencies

• Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or related field
• Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ yr for Associate, 3+ yr 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
• 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 and changing environment and know how to prioritize activities appropriately
• Excellent oral and written communication skills