Process Validation Associate / Engineer

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: * Bachelors’ Degree in Chemical Engineering, Biomedical Engineering, or related * 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