Job Description Summary: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
